Root Coverage Comparing an Allograft to a Bovine Xenograft



Status:Withdrawn
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 120
Updated:6/20/2018
Start Date:June 2016
End Date:December 2017

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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

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.

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.
We found this trial at
1
site
501 South Preston Street
Louisville, Kentucky 40202
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Louisville, KY
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