Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT04818658
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2021-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The survival rate of Hall Technique and Compomer Restorations', 'timeFrame': '5 year', 'description': '1. Successful: restoration satisfactory, no additional treatment required, no clinical sign and symptoms of pulpal pathology or tooth exfoliated,\n2. Minor failure: restoration wear/fracture/loss (restorable) or crown perforation, secondary caries or new caries, reversible pulpitis treated without requiring extraction or pulpotomy,\n3. Major failure: the tooth is broken down (unrestorable), inter-radicular radiolucency or internal root resorption, signs or symptoms of irreversible pulpitis requiring extraction or pulpotomy.\n4. The survival analysis: the restorations are assessed as successful or failure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Caries; Dentin']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars.', 'detailedDescription': 'comparing the survival rate of the conventional restorations with the Hall Technique in carious primary molars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged 5-8 years treated with preformed metal crowns using Hall Technique and compomer restoration', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged five to eight years at the time of dental treatment,\n* patients attending follow-up appointments\n* patients with compomer restoration and Hall restoration in their teeth\n* patients with matching the extent of caries in the two groups\n\nExclusion Criteria:\n\n* patients not attending follow-up appointments\n* patients without both treatment'}, 'identificationModule': {'nctId': 'NCT04818658', 'briefTitle': 'The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration', 'organization': {'class': 'OTHER', 'fullName': 'Bahçeşehir University'}, 'officialTitle': 'The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration: A 5-year Retro-prospective Clinical Study', 'orgStudyIdInfo': {'id': '441555555'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preformed Metal Crowns using Hall Technique', 'interventionNames': ['Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars']}, {'label': 'Compomer Restoration', 'interventionNames': ['Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars']}], 'interventions': [{'name': 'Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars', 'type': 'OTHER', 'description': 'Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.', 'armGroupLabels': ['Compomer Restoration', 'Preformed Metal Crowns using Hall Technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bahcesehir University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Betul Sen Yavuz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bahçeşehir University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bahçeşehir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Betul Sen Yavuz', 'investigatorAffiliation': 'Bahçeşehir University'}}}}