Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
Study NCT ID:
NCT06131294
Status:
COMPLETED
Last Update Posted:
2025-10-23
First Post:
2023-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Evaluation of Two Different Fluoride Applications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097182', 'term': 'Fluoride Treatment'}], 'ancestors': [{'id': 'D005457', 'term': 'Fluoridation'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'patrizia.elkuch-hoch@ivoclar.com', 'phone': '+4232353780', 'title': 'Team Leader Study Management', 'organization': 'Ivoclar Vivadent AG'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Expermental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'osteosarcoma', 'notes': 'One patient had osteosarcoma and was excluded from the study. Osteosarcoma is not related to this clinical study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.2', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-26.3', 'spread': '13.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.5', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-12.2', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: WSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '376.0', 'spread': '404.6', 'groupId': 'OG000'}, {'value': '361.6', 'spread': '296.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- white spot area (WSA)', 'unitOfMeasure': 'WSA in px^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6539', 'spread': '8228', 'groupId': 'OG000'}, {'value': '-5022', 'spread': '5181', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q\n\n\\- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)', 'unitOfMeasure': 'delta Q in %px', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '25.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)', 'unitOfMeasure': 'delta R in %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.3', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '-25.6', 'spread': '12.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.2', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-11.9', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: WSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '446.8', 'spread': '493.0', 'groupId': 'OG000'}, {'value': '444.3', 'spread': '334.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- white spot area (WSA)', 'unitOfMeasure': 'WSA in px^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7105', 'spread': '9351', 'groupId': 'OG000'}, {'value': '-6234', 'spread': '5988', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q\n\n\\- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)', 'unitOfMeasure': 'delta Q in %px', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '32.7', 'spread': '20.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)', 'unitOfMeasure': 'delta R in %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.2', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '-26.1', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.1', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: WSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '238.3', 'spread': '272.5', 'groupId': 'OG000'}, {'value': '266.6', 'spread': '296.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- white spot area (WSA)', 'unitOfMeasure': 'WSA in px^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2628', 'spread': '3216', 'groupId': 'OG000'}, {'value': '-4181', 'spread': '5833', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q\n\n\\- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)', 'unitOfMeasure': 'delta Q in %px', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '29.5', 'spread': '23.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)', 'unitOfMeasure': 'delta R in %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.6', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '-25.3', 'spread': '15.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.5', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-11.6', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)', 'unitOfMeasure': 'percent change (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: WSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '346.4', 'spread': '400.7', 'groupId': 'OG000'}, {'value': '373.5', 'spread': '345.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- white spot area (WSA)', 'unitOfMeasure': 'WSA in px^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta Q', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4819', 'spread': '6078', 'groupId': 'OG000'}, {'value': '-5692', 'spread': '6400', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q\n\n\\- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)', 'unitOfMeasure': 'delta Q in %px', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'PRIMARY', 'title': 'Measurement of White Spot Lesions by QLF Parameters: Delta R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '22.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)', 'unitOfMeasure': 'delta R in %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'SECONDARY', 'title': 'Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'title': 'ICDAS score 0-1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ICDAS score 2', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'ICDAS score 3-6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline', 'description': 'Evaluation of the clinical status of the lesions:\n\n0: Sound tooth surface: No evidence of caries after 5 sec air drying\n\n1. First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying\n2. Distinct visual change in enamel visible when wet, lesion must be visible when dry\n3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying\n4. Underlying dark shadow from dentin\n5. Distinct cavity with visible dentin\n6. Extensive (more than half the surface) distinct cavity with visible dentin', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Severity and Activity of White Spot Lesions by Nyvad Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'title': 'Nyvad score 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nyvad score 1', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Nyvad score 2-3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nyvad score 4-6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nyvad score 7-9', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline', 'description': 'Evaluation of the clinical status of the lesions:\n\n0: Sound\n\n1. Active caries (intact surface)\n2. Active caries (surface discontinuity)\n3. Active caries (cavity)\n4. Inactive caries (intact surface)\n5. Inactive caries (surface discontinuity)\n6. Inactive caries (cavity)\n7. Filling (sound surface)\n8. Filling+active caries\n9. Filling+inactive caries', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'title': '"Regression"', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '"Unchanged"', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '"Progression"', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline to 1 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = ICDAS score increased from 2 to 3\n* "unchanged" = ICDAS score 2\n* "regression" = ICDAS score decreased from 2 to 0 or 1', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Severity and Activity Transition of White Spot Lesions by Nyvad Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'title': '"Regression"', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '"Unchanged"', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '"Progression"', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline to 1 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = Nyvad score changed from 1 to 2 or 5\n* "unchanged" = Nyvad score 1\n* "regression" = Nyvad score changed from 1 to 0 or 4', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'title': '"Regression"', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '"Unchanged"', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '"Progression"', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline to 6 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = ICDAS score increased from 2 to 3\n* "unchanged" = ICDAS score 2\n* "regression" = ICDAS score decreased from 2 to 0 or 1', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Severity and Activity Transition of White Spot Lesions by Nyvad Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'title': '"Regression"', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '"Unchanged"', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '"Progression"', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline to 6 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = Nyvad score changed from 1 to 2 or 5\n* "unchanged" = Nyvad score 1\n* "regression" = Nyvad score changed from 1 to 0 or 4', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'title': '"Regression"', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '"Unchanged"', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '"Progression"', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline to 12 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = ICDAS score increased from 2 to 3\n* "unchanged" = ICDAS score 2\n* "regression" = ICDAS score decreased from 2 to 0 or 1', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}, {'type': 'SECONDARY', 'title': 'Severity and Activity Transition of White Spot Lesions by Nyvad Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'OG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'classes': [{'title': '"Regression"', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '"Unchanged"', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '"Progression"', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Baseline to 12 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = Nyvad score changed from 1 to 2 or 5\n* "unchanged" = Nyvad score 1\n* "regression" = Nyvad score changed from 1 to 0 or 4', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Expermental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'FG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '30', 'numSubjects': '23'}, {'groupId': 'FG001', 'numUnits': '30', 'numSubjects': '23'}]}, {'type': '6 month recall', 'achievements': [{'groupId': 'FG000', 'numUnits': '28', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '28', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '28', 'numSubjects': '21'}, {'groupId': 'FG001', 'numUnits': '28', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'Lesions', 'recruitmentDetails': 'The recruitment period took place between February 2023 and May 2023 in the Restorative Dentistry Department of Medipol University Clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Expermental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.\n\nFluoride Application (Experimental Fluoride Application): Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.'}, {'id': 'BG001', 'title': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.\n\nFluor Protector S: Fluor Protector S is applied on white spot lesions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '14-40 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-21', 'size': 617178, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-26T05:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split-mouth design: Meaning that each patient receives both treatments, but on different teeth.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2023-11-02', 'resultsFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-31', 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: WSA', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- white spot area (WSA)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta Q', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q\n\n\\- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta R', 'timeFrame': 'Baseline', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: WSA', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- white spot area (WSA)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta Q', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q\n\n\\- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta R', 'timeFrame': '1 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: WSA', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- white spot area (WSA)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta Q', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q\n\n\\- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta R', 'timeFrame': '6 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Max)', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (max) (Percentage of maximal fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta F (Average)', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta F (average) (Percentage of average fluorescence loss at lesion sites compared to fluorescence of normal enamel, relative fluorecence loss)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: WSA', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- white spot area (WSA)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta Q', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters: delta Q\n\n\\- delta Q (fluorescence loss in the lesions times with the area of white spot lesions (delta F x WSA); fluorescence loss is negative per definition as enamal has higher mineral content and thus fluorescence than white spot lesions)'}, {'measure': 'Measurement of White Spot Lesions by QLF Parameters: Delta R', 'timeFrame': '12 Month', 'description': 'Evaluation of the change in lesion size of white spot areas and mineral content by measurement of QLF parameters:\n\n\\- delta R (increase of red fluorescence at lesion compared to normal enaml; relative red fluorescence increase)'}], 'secondaryOutcomes': [{'measure': 'Severity of White Spot Lesions by ICDAS II Visual Scoring System (Codes)', 'timeFrame': 'Baseline', 'description': 'Evaluation of the clinical status of the lesions:\n\n0: Sound tooth surface: No evidence of caries after 5 sec air drying\n\n1. First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying\n2. Distinct visual change in enamel visible when wet, lesion must be visible when dry\n3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying\n4. Underlying dark shadow from dentin\n5. Distinct cavity with visible dentin\n6. Extensive (more than half the surface) distinct cavity with visible dentin'}, {'measure': 'Severity and Activity of White Spot Lesions by Nyvad Criteria', 'timeFrame': 'Baseline', 'description': 'Evaluation of the clinical status of the lesions:\n\n0: Sound\n\n1. Active caries (intact surface)\n2. Active caries (surface discontinuity)\n3. Active caries (cavity)\n4. Inactive caries (intact surface)\n5. Inactive caries (surface discontinuity)\n6. Inactive caries (cavity)\n7. Filling (sound surface)\n8. Filling+active caries\n9. Filling+inactive caries'}, {'measure': 'Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)', 'timeFrame': 'Baseline to 1 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = ICDAS score increased from 2 to 3\n* "unchanged" = ICDAS score 2\n* "regression" = ICDAS score decreased from 2 to 0 or 1'}, {'measure': 'Severity and Activity Transition of White Spot Lesions by Nyvad Criteria', 'timeFrame': 'Baseline to 1 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = Nyvad score changed from 1 to 2 or 5\n* "unchanged" = Nyvad score 1\n* "regression" = Nyvad score changed from 1 to 0 or 4'}, {'measure': 'Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)', 'timeFrame': 'Baseline to 6 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = ICDAS score increased from 2 to 3\n* "unchanged" = ICDAS score 2\n* "regression" = ICDAS score decreased from 2 to 0 or 1'}, {'measure': 'Severity and Activity Transition of White Spot Lesions by Nyvad Criteria', 'timeFrame': 'Baseline to 6 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = Nyvad score changed from 1 to 2 or 5\n* "unchanged" = Nyvad score 1\n* "regression" = Nyvad score changed from 1 to 0 or 4'}, {'measure': 'Severity Transition of White Spot Lesions by ICDAS II Visual Scoring System (Codes)', 'timeFrame': 'Baseline to 12 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = ICDAS score increased from 2 to 3\n* "unchanged" = ICDAS score 2\n* "regression" = ICDAS score decreased from 2 to 0 or 1'}, {'measure': 'Severity and Activity Transition of White Spot Lesions by Nyvad Criteria', 'timeFrame': 'Baseline to 12 month', 'description': 'Evaluation of the clinical status of the lesions:\n\n* "progression" = Nyvad score changed from 1 to 2 or 5\n* "unchanged" = Nyvad score 1\n* "regression" = Nyvad score changed from 1 to 0 or 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['white spot lesion'], 'conditions': ['White Spot Lesion']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the remineralizing or preservative effect of two different fluoride-containing products. The main question aims to answer how the mineral content of the active white spot lesions change after the treatment with those two fluoride applications in a split-mouth design by measuring their mineral content via QLF technology.\n\nEach patient will receive both treatments in a split-mouth design. It is comparison between an experimental fluoride application and Fluoride Protector S.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least two active non-cavitated white spot lesions on buccal surfaces of anterior teeth or premolars (ICDAS code 1 and 2; Nyvad score 1) in two different quadrants.\n* Age between 13 and 50 years\n* No untreated caries lesions or periodontal disease\n* No systematic disease or medication (such as antidepressants, antibiotics etc.) that affects salivary flow rate\n* Subjects claimed regular brushing at least twice a day\n* Subjects had to agree to keep the scheduled recall appointments for at least 1 year.\n\nExclusion Criteria:\n\n* Inactive non-cavitated lesions (Nyvad Score 4)\n* Lesions with microcavity, cavitation, chipping or discoloration\n* Lesions at buccal side of the molars\n* Lesions adjacent to restoration\n* Developmental white spot lesions such as enamel hypoplasia\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06131294', 'briefTitle': 'Efficacy Evaluation of Two Different Fluoride Applications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ivoclar Vivadent AG'}, 'officialTitle': 'Evaluation of Effectiveness of a Novel Remineralizing Agent: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'LL4470462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expermental Fluoride Application', 'description': 'The two-step system, consisting of Component A (ammonium fluoride solution) and Component B (calcium fluoride application), will be applied once on the white spot lesions one.', 'interventionNames': ['Device: Fluoride Application (Experimental Fluoride Application)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluor Protector S', 'description': 'The ammonium fluoride gel will be applied once on the white spot lesions.', 'interventionNames': ['Device: Fluor Protector S']}], 'interventions': [{'name': 'Fluoride Application (Experimental Fluoride Application)', 'type': 'DEVICE', 'description': 'Fluoride containing applications are applied on white spot lesions. First solution was air-dried before the second application with the other component was done.', 'armGroupLabels': ['Expermental Fluoride Application']}, {'name': 'Fluor Protector S', 'type': 'DEVICE', 'description': 'Fluor Protector S is applied on white spot lesions.', 'armGroupLabels': ['Fluor Protector S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34230', 'city': 'Istanbul', 'state': 'Esenler', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipo University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Burcu Gözetici, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Medipo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivoclar Vivadent AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}