Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06609720
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2023-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Clinical and Radiographic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D048091', 'term': 'Guided Tissue Regeneration'}], 'ancestors': [{'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups with 2 subgroups, each subgroup receive either ADG or DFDBA'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2024-09-23', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing pocket depth', 'timeFrame': 'Measured at baseline, 6 months and 12 months', 'description': 'According to Ramfjord, clinical parameter measured by UNC periodontal probe from a fixed point to the deepest probing depth. Using stent to standardize the measurements.'}, {'measure': 'Clinical attachment level', 'timeFrame': 'Measured at baseline, 6 months and 12 months', 'description': 'According to Ramfjord, clinical parameter measured by a Naber\\'s probe. Using stent to standard measurements.'}, {'measure': 'Bleeding on probing', 'timeFrame': 'Measured at baseline, 6 months and 12 months', 'description': 'According to Ramfjord, the bleeding at each site observed after probing and recorded positive if bleeding was observed within 30 seconds, if not was recorded as negative.'}], 'secondaryOutcomes': [{'measure': 'Radiographic outcome', 'timeFrame': 'measured at baseline and 1 year follow up', 'description': 'Using CBCT software to analyse furcation volume'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dentin graft, tooth graft'], 'conditions': ['Autogenous Dentin Graft']}, 'descriptionModule': {'briefSummary': 'Randomized clinical and radiographic trial', 'detailedDescription': 'Evaluation of Autogenous Dentin Graft versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\-\n\nPresence of class II and/or ΙΙΙ furcation defects in mandibular first or second molars according to criteria outlined by Hamp et. al. 1975.\n\n* Horizontal probing depth ≥3 mm using Naber's probe.\n* Clinical attachment level ≥3 mm measured from cemento-enamel junction (CEJ) till the deepest probing depth.\n* Evidence of radiolucency in the furcation area on panoramic radiograph.\n* Patients who will be assigned for groups (I and II) should present with teeth required for extraction due to advanced periodontal bone loss or other indications such as hopeless wisdom teeth or orthodontic indications or unrestorable fractured teeth as a source for autogenous dentin graft (ADG).\n\nExclusion Criteria:\n\n* Medically compromised patients and systemic conditions precluding periodontal surgery.\n\n * Mandibular first or second molars with root caries or endodontic treatment.\n * Smokers, diabetics, pregnant or lactating women.\n * History of chemotherapy, radiotherapy in head and/or neck region.\n * Bisphosphonate therapy."}, 'identificationModule': {'nctId': 'NCT06609720', 'briefTitle': 'Randomized Clinical and Radiographic Study', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Evaluation of Autogenous Dentin Graft Versus Demineralized Freeze-Dried Bone Allograft in the Treatment of Class ΙΙ and ΙΙΙ Mandibular Furcation Defects', 'orgStudyIdInfo': {'id': 'OMPDR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 subgroup A', 'description': 'Grade II furcation involvement treated with autogenous dentin graft', 'interventionNames': ['Procedure: (guided tissue regeneration)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1 Subgroup B', 'description': 'Grade II furcation involvement treated with demineralized freeze-dried bone allograft', 'interventionNames': ['Procedure: (guided tissue regeneration)']}, {'type': 'EXPERIMENTAL', 'label': 'Group II subgroup A', 'description': 'Grade III furcation involvement treated with Autogenous dentin graft', 'interventionNames': ['Procedure: (guided tissue regeneration)']}, {'type': 'EXPERIMENTAL', 'label': 'Group II subgroup B', 'description': 'Grade III furcation involvement treated with demineralized freeze-dried bone allograft', 'interventionNames': ['Procedure: (guided tissue regeneration)']}], 'interventions': [{'name': '(guided tissue regeneration)', 'type': 'PROCEDURE', 'description': 'Randomized clinical and radiographic trial', 'armGroupLabels': ['Group 1 Subgroup B', 'Group 1 subgroup A', 'Group II subgroup A', 'Group II subgroup B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of dentistry', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Banan L Amer, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}, {'name': 'Samia A Darwish, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer at periodontology department, Principal Investigator, MSC', 'investigatorFullName': 'Banan Lotfy Mohamed Amer', 'investigatorAffiliation': 'Tanta University'}}}}