Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-01 @ 7:47 PM
Study NCT ID:
NCT03582995
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2018-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C440568', 'term': 'Alloderm'}, {'id': 'D014183', 'term': 'Transplantation, Heterologous'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2018-06-13', 'studyFirstSubmitQcDate': '2018-07-09', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of root coverage', 'timeFrame': '4 months', 'description': 'Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100'}], 'secondaryOutcomes': [{'measure': 'Tissue thickness', 'timeFrame': '4 months', 'description': 'The thickness of the gingival tissue will be'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recession, Gingival']}, 'descriptionModule': {'briefSummary': 'The study will consist of a randomized controlled clinical study trial comparing the results of coronally positioned flap with AlloDerm GBR plus bovine derived xenograft versus coronally positioned tunnel with AlloDerm GBR plus bovine derived xenograft in approximately 30 patients (15 per group). All materials used in the study are FDA approved.', 'detailedDescription': 'Patients will be assigned to one of two treatment groups. In the positive control group, BX will be placed over the root and bone surface of the defect, covered with ADM GBR® and sutured using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle (Dodge et. al, 1998). The coronally positioned flap will be sutured separately and coronally positioned using a continuous sling suture technique (papilla to papilla sutures) with a Maxon 5-0, 3/8 circle 13 mm needle. In the test group, BX will be placed over the root and bone surface of the defect, covered with ADM GBR® and sutured together using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle. The coronally positioned tunnel will be sutured together and coronally positioned using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle.\n\nPost-operative instructions will be given to the patients along with prescriptions, in appropriate cases, for systemic doxycycline 100 mg once a day for 14 days; an anti-inflammatory agent (naproxen 375 mg q12h for 7 days); an analgesic (hydrocodone/acetaminophen 5/325mg q6-8h prn pain); a steroid, Medrol dose pack, 21 tablets of 4 mg methylprednisolone; 6 tablets on day 1, 5 on day 2, decrease by 1/day until last tablet dose on day 6, or dexamethazone 1mg, 18 tablets, 3 tablets/day for 1st3 days, 2/day for the next 3 days, 1/day for the last 3 days (always taken in the morning).\n\nAll patients will be seen at week 1 or 2, 4, 8, 16 and 24, at which time the final exam will be completed. Sutures will be removed between weeks 4-8, as indicated. Post-operative visits will consist of supragingival plaque removal and oral hygiene reinforcement. Any patient who develops any adverse reaction to the materials used or shows attachment loss ≥2.0 mm will be exited from the study and will receive the appropriate treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).\n\nB. The mucogingival defect must be on a non-molar tooth.\n\nC. Patients must be ≥ 18 years of age.\n\nExclusion Criteria:\n\nA. Patients with debilitating systemic or diseases that significantly affect the periodontium.\n\nB. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).\n\nC. Patients requiring antibiotic prophylaxis.\n\nD. Root surface restorations at the site of recession.\n\nE. No detectable CEJ\n\nF. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.\n\nG. Patients who are pregnant or lactating.\n\nH. Patients who use tobacco products (smoking or smokeless tobacco).\n\nI. Patients with alcohol abuse problems.\n\nJ. Patients undergoing long-term steroid therapy.\n\nK. History of previous root coverage procedures, graft or GTR, on the test teeth.\n\nL. Patients who fail to complete the informed consent form'}, 'identificationModule': {'nctId': 'NCT03582995', 'briefTitle': 'Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous Xenograft Using Either a Coronally Positioned Tunnel or Coronally Positioned Flap', 'orgStudyIdInfo': {'id': '18.0467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Flap Surgery for root coverage with Alloderm and xenograft', 'description': 'Root coverage surgery using a flap technique', 'interventionNames': ['Procedure: Flap Surgery for root coverage with Alloderm and xenograft']}, {'type': 'EXPERIMENTAL', 'label': 'Tunnel Surgery for root coverage with Alloderm and xenograft', 'description': 'Root coverage surgery using a tunnel technique', 'interventionNames': ['Procedure: Tunnel Surgery for root coverage with Alloderm and xenograft']}], 'interventions': [{'name': 'Flap Surgery for root coverage with Alloderm and xenograft', 'type': 'PROCEDURE', 'description': 'A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage', 'armGroupLabels': ['Flap Surgery for root coverage with Alloderm and xenograft']}, {'name': 'Tunnel Surgery for root coverage with Alloderm and xenograft', 'type': 'PROCEDURE', 'description': 'A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.', 'armGroupLabels': ['Tunnel Surgery for root coverage with Alloderm and xenograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Graduate Periodontics, UofL School of Dentistry', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Henry Greenwell, DMD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director', 'investigatorFullName': 'Henry Greenwell', 'investigatorAffiliation': 'University of Louisville'}}}}