Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT05001035
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2021-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Biomimetic Materials on White Spot Lesions in Enamel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Split mouth technique'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in remineralization from base line to time limit', 'timeFrame': 'Immediate and one month and two months', 'description': 'Change in its density in digital xray'}, {'measure': 'changes of appearance from base line photograph to time limit', 'timeFrame': 'Immediate and one month and two months', 'description': 'White spots disappear on digital photography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['White Spot Lesion']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate: 1- The remineralizing effect of different biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM) and bioactive glass nanoparticles) on white spot lesions in enamel. 2- The clinical efficacy of these agents on disappearance of these white spots.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total of 21 patients enrolled in this study will be selected having at least 4 teeth (one on each quadrant) which will be extracted for orthodontic treatment.\n* These patients will be selected according to age groups between 15-25 years old\n* good oral hygiene\n* free of destroying habits for dental tissues\n\nExclusion Criteria:\n\n* Bruxism\n* soft drinks consumption\n* acid regurgitation, etc.).\n* Selected teeth having any cracks, malformations, dysplasia or caries.'}, 'identificationModule': {'nctId': 'NCT05001035', 'briefTitle': 'Effect of Different Biomimetic Materials on White Spot Lesions in Enamel', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Effect of Different Biomimetic Materials on White Spot Lesions in Enamel', 'orgStudyIdInfo': {'id': 'OP-P-018-001'}, 'secondaryIdInfos': [{'id': 'OPDEN-107-1-G', 'type': 'OTHER', 'domain': 'Faculty of dentistry Alazhar University girls branch'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc carbonated hydroxy apatite', 'description': 'Toothpaste to be added on white spot lesions in dental enamel', 'interventionNames': ['Other: Time of assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Bioactive glass', 'description': 'Toothpaste to be added on white spot lesions in dental enamel', 'interventionNames': ['Other: Time of assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Poly amido amine', 'description': 'Resinous material to be painted on white spot lesions in dental enamel', 'interventionNames': ['Other: Time of assessment']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No material to be added'}], 'interventions': [{'name': 'Time of assessment', 'type': 'OTHER', 'description': 'Immediate and after one month and after two months', 'armGroupLabels': ['Bioactive glass', 'Poly amido amine', 'Zinc carbonated hydroxy apatite']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of dental medicine for girls branch of Alazhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dental specialist at benha teaching hospital', 'investigatorFullName': 'Eptesam Atef', 'investigatorAffiliation': 'Benha University'}}}}