Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous

Recession, Gingival Clinical Trial

Official title:

Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous Xenograft Using Either a Coronally Positioned Tunnel or Coronally Positioned Flap

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582995
• Other study ID #: 18.0467
• Status: Completed
• Phase: N/A
• Start date: October 23, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Recession, Gingival

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
United States	Graduate Periodontics, UofL School of Dentistry	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of root coverage	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	4 months
Secondary	Tissue thickness	The thickness of the gingival tissue will be	4 months