Clinical trial NCT02810067: Root Coverage Comparing an Allograft to a Bovine Xenograft
Official title: Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Donor Materials
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gingival Recession
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent root coverage
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics, UofL School of Dentistry
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References: