Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous



Status:Not yet recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:7/14/2018
Start Date:July 2018
End Date:May 2019
Contact:Jodie Lusby, DMD
Email:jblusb01@louisville.edu
Phone:859-816-2701

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Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous Xenograft Using Either a Coronally Positioned Tunnel or Coronally Positioned Flap

The study will consist of a randomized controlled clinical study trial comparing the results
of coronally positioned flap with AlloDerm GBR plus bovine derived xenograft versus coronally
positioned tunnel with AlloDerm GBR plus bovine derived xenograft in approximately 30
patients (15 per group). All materials used in the study are FDA approved.

Patients will be assigned to one of two treatment groups. In the positive control group, BX
will be placed over the root and bone surface of the defect, covered with ADM GBR® and
sutured using a continuous sling suture technique (line angle to line angle) with a Maxon
5-0, 3/8 circle 13 mm needle (Dodge et. al, 1998). The coronally positioned flap will be
sutured separately and coronally positioned using a continuous sling suture technique
(papilla to papilla sutures) with a Maxon 5-0, 3/8 circle 13 mm needle. In the test group, BX
will be placed over the root and bone surface of the defect, covered with ADM GBR® and
sutured together using a continuous sling suture technique (line angle to line angle) with a
Maxon 5-0, 3/8 circle 13 mm needle. The coronally positioned tunnel will be sutured together
and coronally positioned using a continuous sling suture technique (line angle to line angle)
with a Maxon 5-0, 3/8 circle 13 mm needle.

Post-operative instructions will be given to the patients along with prescriptions, in
appropriate cases, for systemic doxycycline 100 mg once a day for 14 days; an
anti-inflammatory agent (naproxen 375 mg q12h for 7 days); an analgesic
(hydrocodone/acetaminophen 5/325mg q6-8h prn pain); a steroid, Medrol dose pack, 21 tablets
of 4 mg methylprednisolone; 6 tablets on day 1, 5 on day 2, decrease by 1/day until last
tablet dose on day 6, or dexamethazone 1mg, 18 tablets, 3 tablets/day for 1st3 days, 2/day
for the next 3 days, 1/day for the last 3 days (always taken in the morning).

All patients will be seen at week 1 or 2, 4, 8, 16 and 24, at which time the final exam will
be completed. Sutures will be removed between weeks 4-8, as indicated. Post-operative visits
will consist of supragingival plaque removal and oral hygiene reinforcement. Any patient who
develops any adverse reaction to the materials used or shows attachment loss ≥2.0 mm will be
exited from the study and will receive the appropriate treatment.

Inclusion Criteria:

A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).

B. The mucogingival defect must be on a non-molar tooth.

C. Patients must be ≥ 18 years of age.

Exclusion Criteria:

A. Patients with debilitating systemic or diseases that significantly affect the
periodontium.

B. Patients with a known allergy to any of the materials that will be used in the study,
including systemic antibiotics (tetracycline and doxycycline).

C. Patients requiring antibiotic prophylaxis.

D. Root surface restorations at the site of recession.

E. No detectable CEJ

F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.

G. Patients who are pregnant or lactating.

H. Patients who use tobacco products (smoking or smokeless tobacco).

I. Patients with alcohol abuse problems.

J. Patients undergoing long-term steroid therapy.

K. History of previous root coverage procedures, graft or GTR, on the test teeth.

L. Patients who fail to complete the informed consent form
We found this trial at
1
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501 South Preston Street
Louisville, Kentucky 40202
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Louisville, KY
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