Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-06 @ 7:23 PM
Study NCT ID:
NCT06205459
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2020-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Marginal Acquisition With Thermacut Bur Vs. Functional Crown Lengthening in Deep Carious Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2020-04-26', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'marginal integrity', 'timeFrame': 'immediate post operative, 3 month, 6 month and 1 year', 'description': 'using modified USPHS criteria'}], 'primaryOutcomes': [{'measure': 'patient satisfaction: visual analogue scale', 'timeFrame': 'immediate post operative, 3 month, 6 month and 1 year', 'description': 'using visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Pocket depth and biological width', 'timeFrame': 'immediate post operative, 3 month, 6 month and 1 year', 'description': 'Graded Periodontal Probe and (digital radiograph) bitewing with paralleling technique'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Caries']}, 'descriptionModule': {'briefSummary': 'this clinical trial is conducted to compare between deep marginal acquistion by the means of thermacut bur Vs. functional crown lengthening in exposing deep subgingival interproximal cervical lesions', 'detailedDescription': 'Deep subgingival margins pose a great difficulty during restorative work with composite restorations. Exposing cavity margins is paramount in order to attain proper isolation, matrix adaptation and composite placement.\n\nSeveral methods have been proposed to overcome the problem of exposing deep margins; functional crown lengthening is considered the gold standard of care regarding exposure of deep margins.\n\nHowever, functional crown lengthening can pose many problems including the risk of root exposure, furcation involvement and compromising crown root ratio, besides risk of thread exposure if it is done beside implant, removal of bone from adjacent teeth and from buccal and lingual walls in order to create smooth bone architecture, and the complications of surgery such as post-operative pain, inflammation and edema and the risk of excessive bleeding.\n\nDeep marginal acquisition and deep marginal extension (DMA \\& DME) are considered as a viable option in treating deep subgingival extended margins.\n\nSeveral methods regarding deep marginal acquisition have been proposed including the use of diode laser and Electrosurgery, there is another protocol for exposing the gingival seat by the use of thermacut bur.\n\nThe rationale behind conducting this research is to propose an easy and predictable way to expose deep subgingival margins, without the need to perform surgical intervention.\n\nThe technique is done by clinicians with good outcomes, but never been tested or validated, this study is performed to verify whether this test should be validated or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subject not less than 18 years of age\n\n1. Males or females\n2. Community-dwelling\n3. Have at least one deep subgingival interproximal carious lesion.\n4. Can comply to oral hygiene measures or with good oral hygiene\n5. Have sufficient cognitive ability to\n\n5- Understand consent procedures.\n\nExclusion Criteria:\n\n1. Patients less than 18 years old.\n2. Disabilities:\n3. Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, hypertensive, epileptic).\n4. Lack of compliance.\n5. Gingival hyperplasia, blood disorder.\n6. Cognitive impairment.\n7. Attachment loss signs of periodontal disease.'}, 'identificationModule': {'nctId': 'NCT06205459', 'briefTitle': 'Deep Marginal Acquisition With Thermacut Bur Vs. Functional Crown Lengthening in Deep Carious Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Deep Marginal Acquisition With Thermacut Bur Versus Functional Crown Lengthening in Management of Deep Subgingival Interproximal Carious Lesions: A One Year Follow-up Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'thermacut bur dentsply'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'deep marginal acquisition using thermacut bur from dentsply', 'interventionNames': ['Procedure: deep marginal acquisition using thermacut bur']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'functional crown lengthening', 'interventionNames': ['Procedure: deep marginal acquisition using thermacut bur']}], 'interventions': [{'name': 'deep marginal acquisition using thermacut bur', 'type': 'PROCEDURE', 'otherNames': ['thermacut bur from dentsply'], 'description': "thermacut bur is a tool which doesn't contain any abrasives so it is much safer on the root surface of both prepared and adjacent teeth, and yields better treatment outcome in cases when exposing deep margins is needed.", 'armGroupLabels': ['control', 'intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'operative department', 'role': 'CONTACT', 'email': 'dentmail@dentistry.cu.edu.eg', 'phone': '+201002159535'}], 'facility': 'Faculty of dentistry Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master degree candidate, Conservative dentistry department, faculty of dentistry', 'investigatorFullName': 'Ahmed Khairy Elmorsy', 'investigatorAffiliation': 'Cairo University'}}}}