Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT01496456
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2011-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Radiographic Progression of Infiltrated Caries Lesions In-vivo
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D014076', 'term': 'Tooth Diseases'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcpete@umich.edu', 'title': 'Dr. Mathilde C Peters', 'organization': 'UMichigan'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Lesion Infiltration', 'description': 'Resin infiltration of caries lesion in addition to SOC caries management by preventative measures\n\nSOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Preventative Measures', 'description': 'Caries management by preventative measures only\n\nSOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesion Infiltration', 'description': 'Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.'}, {'id': 'OG001', 'title': 'Preventative Measures', 'description': 'SOC Caries management by preventative measures only.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ordinal logistic regression, controlled for baseline lesion size and for correlation among pairs of teeth using the GEE method.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 3 years', 'description': 'Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions', 'populationDescription': 'Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR).'}, {'type': 'SECONDARY', 'title': 'Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesion Infiltration', 'description': 'Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.'}, {'id': 'OG001', 'title': 'Preventative Measures', 'description': 'Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation\n\nBaseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ordinal logistic regression, controlled for correlation among pairs of teeth using the GEE method.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 3 years', 'description': 'Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions'}, {'type': 'SECONDARY', 'title': 'Lesion Survival After 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesion Infiltration', 'description': 'Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.'}, {'id': 'OG001', 'title': 'Preventative Measures', 'description': 'Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation\n\nBaseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0077', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Discreet Time Survival Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Controlled for correlation among tooth pairs (GEE model).'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Discrete time survival analysis of time to first lesion progression.', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions', 'populationDescription': 'Radiographic lesion increase by PWA+DSR. A tooth was included up until the time the lesion first increased.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lesion Infiltration and Preventative Management Only', 'description': 'Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth).\n\nA) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only.\n\n\\--- Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Baseline', 'achievements': [{'comment': 'Baseline group started with 16 patients.', 'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': '1-yr Recall', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': '2-yr Recall', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': '3-yr Final Recall', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Recruitment was not as expected and halted after one year. Local options to enhance patient accrual were exhausted. The total patient pool was small, but of sufficient scientific value to continue and complete the study.', 'preAssignmentDetails': 'Paired, split-mouth study design: Each patient received at least 1 pair of 2 treatments (one of each arm). Eligible tooth pairs selected for similarity. Random allocation of treatment to study teeth of each tooth pair.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lesion Infiltration and Preventative Management Only', 'description': 'Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only\n\nSOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'spread': '7.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Enrolled: 17 patients; 1 patient was not treated according to protocol. Baseline: 16 patients with 22 tooth pairs.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-09', 'studyFirstSubmitDate': '2011-12-09', 'resultsFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-12', 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)', 'timeFrame': 'Baseline through 3 years', 'description': 'Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).'}], 'secondaryOutcomes': [{'measure': 'Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories', 'timeFrame': 'Baseline through 3 years', 'description': 'Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).'}, {'measure': 'Lesion Survival After 3 Years', 'timeFrame': '3 years', 'description': 'Discrete time survival analysis of time to first lesion progression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental caries', 'Proximal surfaces', 'Posterior teeth', 'Carious lesions', 'Tooth diseases', 'Preventive therapy'], 'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment. J Dent Res 92(Spec Iss A):377, 2013.'}, {'pmid': '25080756', 'type': 'RESULT', 'citation': 'Resin infiltration effects in a caries-active environment. J Calif Dent Assoc. 2014 Jun;42(6):372. No abstract available.'}, {'type': 'RESULT', 'citation': 'Peters MC, Bula A, Nedley M, Davis W, Bayne SC. Efficacy of Resin Infiltration in High Caries-Active Environment -- 3YR Results. J Dent Res 93(Spec Iss B): 1017, 2014.'}]}, 'descriptionModule': {'briefSummary': 'This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.', 'detailedDescription': 'A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14-35 year old subjects\n* decayed-missing-filled permanent teeth (DMFT) ≥ 3\n* having at least two early caries lesions in approximal posterior tooth surfaces\n* lesion visible on radiograph\n\nExclusion Criteria:\n\n* Current participation in another clinical study\n* Medically compromised subjects\n* Hyposalivation\n* Pregnancy\n* Allergic to methylmethacrylates\n* Allergic to latex\n* Symptomatic teeth'}, 'identificationModule': {'nctId': 'NCT01496456', 'acronym': 'ICON', 'briefTitle': 'Radiographic Progression of Infiltrated Caries Lesions In-vivo', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Radiographic Progression of Infiltrated Caries Lesions In-vivo', 'orgStudyIdInfo': {'id': 'PG#N010508'}, 'secondaryIdInfos': [{'id': '10-PAF03721', 'type': 'OTHER', 'domain': 'U-Michigan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Preventative measures', 'description': 'Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation', 'interventionNames': ['Behavioral: Caries management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lesion infiltration', 'description': 'Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation', 'interventionNames': ['Device: Resin infiltration', 'Behavioral: Caries management']}], 'interventions': [{'name': 'Resin infiltration', 'type': 'DEVICE', 'otherNames': ['ICON (DMG, Germany)'], 'description': 'Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy', 'armGroupLabels': ['Lesion infiltration']}, {'name': 'Caries management', 'type': 'BEHAVIORAL', 'otherNames': ['Home use of over-the-counter oral health products'], 'description': 'Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements', 'armGroupLabels': ['Lesion infiltration', 'Preventative measures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo Medical Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Mathilde C Peters, DMD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'DMG Dental Material Gesellschaft mbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mathilde Peters, DMD, PhD', 'investigatorAffiliation': 'University of Michigan'}}}}