Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-04-13 @ 7:48 AM
Study NCT ID:
NCT02487758
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-06-29', 'lastUpdatePostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in post-extraction site to 4 month change in crestal osseous width', 'timeFrame': '4 months', 'description': 'Changes in post-extraction to 4 month change in ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.'}], 'secondaryOutcomes': [{'measure': 'Change in Soft tissue thickness', 'timeFrame': '4 months', 'description': 'Soft tissue thickness measurements taken with a #40 endodontic reamer.'}, {'measure': 'Percent osseous tissue', 'timeFrame': '4 months', 'description': 'A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Jaw, Edentulous, Partially']}, 'descriptionModule': {'briefSummary': 'Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting', 'detailedDescription': 'Thirty patients will be treated using the principles of guided bone regeneration and ridge preservation. Fifteen test patients will receive the flapless technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. The positive control group of fifteen patients will receive the flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.\n2. Healthy male or female who is at least 18 years old.\n3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.\n\nExclusion Criteria:\n\n1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.\n2. Presence or history of osteonecrosis of jaws.\n3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.\n4. Patients who have been treated with oral bisphosphonates for more than three years.\n5. Patients with an allergy to any material or medication used in the study.\n6. Previous head and neck radiation therapy.\n7. Chemotherapy in the previous 12 months.\n8. Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT02487758', 'briefTitle': 'Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting', 'orgStudyIdInfo': {'id': '15.0531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ridge preservation Flap', 'description': 'The flap procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal.', 'interventionNames': ['Procedure: Ridge Preservation']}, {'type': 'EXPERIMENTAL', 'label': 'Ridge preservation Flapless', 'description': 'The test will be a flapless technique with tunneling and an intramucosal vertical incision on the buccal.', 'interventionNames': ['Procedure: Ridge Preservation']}], 'interventions': [{'name': 'Ridge Preservation', 'type': 'PROCEDURE', 'description': 'Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting', 'armGroupLabels': ['Ridge preservation Flap', 'Ridge preservation Flapless']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Henry Greenwell, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Periodontics Director', 'investigatorFullName': 'Henry Greenwell', 'investigatorAffiliation': 'University of Louisville'}}}}