Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous

NCT ID: NCT03582995

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2021-04-30

Brief Summary

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.

Detailed Description

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.

Post-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).

All 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.

Conditions

Recession, Gingival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Flap Surgery for root coverage with Alloderm and xenograft

Root coverage surgery using a flap technique

Group Type: ACTIVE_COMPARATOR

Flap Surgery for root coverage with Alloderm and xenograft

Intervention Type: PROCEDURE

A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage

Tunnel Surgery for root coverage with Alloderm and xenograft

Root coverage surgery using a tunnel technique

Group Type: EXPERIMENTAL

Tunnel Surgery for root coverage with Alloderm and xenograft

Intervention Type: PROCEDURE

A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.

Interventions

Flap Surgery for root coverage with Alloderm and xenograft

A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage

Intervention Type: PROCEDURE

Tunnel Surgery for root coverage with Alloderm and xenograft

A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).

B. The mucogingival defect must be on a non-molar tooth.

C. Patients must be ≥ 18 years of age.

Exclusion Criteria

A. Patients with debilitating systemic or diseases that significantly affect the periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis.

D. Root surface restorations at the site of recession.

E. No detectable CEJ

F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.

G. Patients who are pregnant or lactating.

H. Patients who use tobacco products (smoking or smokeless tobacco).

I. Patients with alcohol abuse problems.

J. Patients undergoing long-term steroid therapy.

K. History of previous root coverage procedures, graft or GTR, on the test teeth.

L. Patients who fail to complete the informed consent form

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Henry Greenwell

Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Greenwell, DMD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Graduate Periodontics, UofL School of Dentistry

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

18.0467

Identifier Type: -

Identifier Source: org_study_id