Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 9:15 AM
Study NCT ID:
NCT04671134
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2020-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'state of lesions', 'timeFrame': '6 months.', 'description': 'Digital scores'}], 'secondaryOutcomes': [{'measure': 'shade of lesions', 'timeFrame': '6 months', 'description': 'Digital scores'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['White Spot Lesion']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin modified glass ionomer varnish on color shade and state of white spot lesions immediately, after 3 months, and after 6 months. (An in vivo study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients included in this clinical trial were less than 30 years old.\n2. Patients with good general health.\n3. Patients who will agree to the consent and will commit to follow-up period.\n4. Fully erupted anterior teeth with no cavitated lesions.\n\nExclusion Criteria:\n\n1. Patients with any systemic disease that may affect normal healing.\n2. Patient with bad oral hygiene.\n3. Tetracycline or florosis staining.\n4. Patients who could/would not participate in all times of follow-up.\n5. Untreated periodontal disease was not allowed.\n6. Active caries or defective Restorations in 6 anterior teeth.\n7. Bleaching history\n8. Patients participating in more than 1 dental study.\n9. Patient received fluoride varnish before.'}, 'identificationModule': {'nctId': 'NCT04671134', 'briefTitle': 'Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)', 'orgStudyIdInfo': {'id': '581/3287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biomimetic remineralizing agent', 'interventionNames': ['Other: Biomimetic remineralizing agent', 'Other: Resin Modified Glass Ionomer Varnish']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Resin modified glass ionomer varnish', 'interventionNames': ['Other: Biomimetic remineralizing agent', 'Other: Resin Modified Glass Ionomer Varnish']}], 'interventions': [{'name': 'Biomimetic remineralizing agent', 'type': 'OTHER', 'description': 'Self-assempling peptide', 'armGroupLabels': ['Biomimetic remineralizing agent', 'Resin modified glass ionomer varnish']}, {'name': 'Resin Modified Glass Ionomer Varnish', 'type': 'OTHER', 'description': 'Resin Modified Glass Ionomer Varnish', 'armGroupLabels': ['Biomimetic remineralizing agent', 'Resin modified glass ionomer varnish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11751', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al-Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Hany Helmy Elsayed Mohammed', 'investigatorAffiliation': 'Al-Azhar University'}}}}