Root Coverage Comparing an Allograft to a Bovine Xenograft

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02810067
• Other study ID #: 17.0534
• Status: Withdrawn
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Tunnel + AlloDerm
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm).
• Tunnel + Novomatrix
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).

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	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