Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT05314660
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2022-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-27', 'mcpReleaseN': 2, 'releaseDate': '2024-02-01'}], 'estimatedResultsFirstSubmitDate': '2024-02-01'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C024633', 'term': 'silver diamine fluoride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The operator must know the group in which the participant is enrolled so as to provide and carry out the intended treatment protocol. Randomization was preformed by block randomization by the nurse.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 equal groups receiving 3 different protocols'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2022-03-24', 'studyFirstSubmitQcDate': '2022-04-03', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.', 'timeFrame': '1 year', 'description': 'Absence of pains and signs of pulpal involvement and caries classified as inactive by ICDAS was considered a successful outcome. When the lesions appeared shiny and felt hard on probing (for SDF and UCT). For ART success was measures by the presence of intact restoration and avsence of pain.'}], 'secondaryOutcomes': [{'measure': 'Early childhood oral health impact scale (ECOHIS)', 'timeFrame': '3 months', 'description': 'Comprises 13 questions of four domains; child symptoms, function, pscychology and social interactions. Questionnaire answered at the first appointment and 21 days later. Lowest score is 0, highest is 52 and higher score indicates poor oral health related quality of life.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caries Arrest']}, 'referencesModule': {'references': [{'pmid': '39664835', 'type': 'DERIVED', 'citation': 'Hamza BE, Attia NM, Abdellatif AM, Hegazy SA. Arresting Active Carious Lesions Using Minimal Intervention Dentistry among a Group of Preschool Children: A Randomized Controlled Clinical Trial. Int J Clin Pediatr Dent. 2024 Sep;17(9):1018-1024. doi: 10.5005/jp-journals-10005-2927.'}]}, 'descriptionModule': {'briefSummary': 'Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.', 'detailedDescription': '135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.\n\nThe parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy children aged 3-5\n* residents of mansoura city\n* having at least one carious dentine lesion\n\nExclusion Criteria:\n\n* large carious lesions approximating the pulp\n* signs of pulpitis, fistula, abscess.'}, 'identificationModule': {'nctId': 'NCT05314660', 'briefTitle': 'Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.', 'orgStudyIdInfo': {'id': 'A22080120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Silver diamine fluoride group', 'description': 'Application of 38% SDF.', 'interventionNames': ['Drug: 38 % silver diamine fluoride']}, {'type': 'EXPERIMENTAL', 'label': 'Atrumatic restorative technique', 'interventionNames': ['Procedure: Atraumatic restorative technique']}, {'type': 'EXPERIMENTAL', 'label': 'Ultra conservative treatment (UCT)', 'interventionNames': ['Procedure: Ultra conservative dentistry']}], 'interventions': [{'name': '38 % silver diamine fluoride', 'type': 'DRUG', 'description': 'Application of 38% SDF on carious dentine lesions.', 'armGroupLabels': ['Silver diamine fluoride group']}, {'name': 'Atraumatic restorative technique', 'type': 'PROCEDURE', 'description': 'Hand excavation of carious dentine followed by application of Glass ionomer', 'armGroupLabels': ['Atrumatic restorative technique']}, {'name': 'Ultra conservative dentistry', 'type': 'PROCEDURE', 'description': 'Removal of soft dentine and enlarging of cavity to control bio film', 'armGroupLabels': ['Ultra conservative treatment (UCT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53111', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Basma Hamza', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data regarding the A-ECOHIS will be available to share if needed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}