NCT02810067

Root Coverage Comparing an Allograft to a Bovine Xenograft

Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Donor Materials

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials

Detailed description

Thirty patients will be treated: 15 with a coronally positioned tunnel technique with NovaDerm® xenograft using continuous sling suture to secure both the graft and the flap (test treatment) and 15 with a coronally positioned tunnel technique with AlloDerm® allograft using continuous sling suture to secure both the graft and the flap (control treatment). Sutures used for the control group will be Maxon 5-0, 3/8 circle 13 mm needle for both the test and control groups. The coronally positioned tunnel technique was previously described by Edwards Pat Allen (E.P. Allen, Center for Advanced Dental Education, Dallas, Texas; course manual). Each patient will provide at least one Miller Class I or II facial recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either the test or control treatment. Mentor will toss the coin immediately prior to suturing. Patients will be evaluated postoperatively for a period of 4 months. The examiner will be blinded and will not be aware of the patient treatment at any time during the term of the study. Three exams for measurements will be performed per patient on total: preoperative, at week eight and 16 (4 months) postoperatively.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	Tunnel + AlloDerm	A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm).
PROCEDURE	Tunnel + Novomatrix	A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-06-22
• Last updated: 2018-06-18

Locations

1 site across 1 country: United States