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

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

Study Overview

• Status: Withdrawn
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Tunnel + AlloDerm; Procedure: Tunnel + Novomatrix

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Graduate Periodontics, UofL School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
• The mucogingival defect must be on a non-molar tooth.
• Patients must be at least 18 years of age.

Exclusion Criteria:

• Patients with debilitating systemic or diseases that significantly affect the periodontium.
• Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
• Patients requiring antibiotic prophylaxis.
• Root surface restorations at the site of recession.
• No detectable CEJ
• Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
• Patients who are pregnant or lactating.
• Patients who use tobacco products (smoking or smokeless tobacco).
• Patients with alcohol abuse problems.
• Patients undergoing long-term steroid therapy.
• History of previous root coverage procedures, graft or GTR, on the test teeth.
• Patients who fail to complete the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tunnel + AlloDerm®; A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®).	Procedure: Tunnel + AlloDerm; A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm).; Other Names: AlloDerm®
Experimental: Tunnel + Novomatrix; A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).	Procedure: Tunnel + Novomatrix; A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).; Other Names: Novomatrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent 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

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Henry Greenwell, DMD, MS, University Of Louisville

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 17.0534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No