- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582995
Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous
Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous Xenograft Using Either a Coronally Positioned Tunnel or Coronally Positioned Flap
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Graduate Periodontics, UofL School of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Flap Surgery for root coverage with Alloderm and xenograft
Root coverage surgery using a flap technique
|
A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage
|
Experimental: Tunnel Surgery for root coverage with Alloderm and xenograft
Root coverage surgery using a tunnel technique
|
A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of root coverage
Time Frame: 4 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tissue thickness
Time Frame: 4 months
|
The thickness of the gingival tissue will be
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henry Greenwell, DMD, MS, University of Louisville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18.0467
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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