Thick vs. Thin Acellular Dermal Matrix (ADM) (ADM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03392038
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Brief Summary:
To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: Thin ADM Procedure: Thick ADM Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Root Coverage Using the Coronally Positioned Tunnel Technique Comparing Thick Versus Thin Acellular Dermal Matrix
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: Thin ADM
Periodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR)
Procedure: Thin ADM
Use of soft tissue allograft for root coverage
Other Name: Thin acellular dermal matrix (ADM GBR)

Active Comparator: Thick ADM
Periodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM)
Procedure: Thick ADM
Periodontal surgical procedure to coronally position the tissue over the ADM allograft
Other Name: Thick acellular dermal matrix graft (ADM)

Primary Outcome Measures :
  1. Percent root coverage [ Time Frame: Six months ]
    Between 0 and 100%

Secondary Outcome Measures :
  1. Creeping Attachment [ Time Frame: Six months ]
    Amount in millimeters

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 acceptable oral hygiene levels at the test and adjacent teeth.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03392038

Contact: Elliott DeWeese, DMD 502-387-5778

United States, Kentucky
Graduate Periodontics, UofL School of Dentistry Recruiting
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Principal Investigator: Henry Greenwell University of Louisville

Responsible Party: Henry Greenwell, Director, Graduate Periodontics, University of Louisville Identifier: NCT03392038     History of Changes
Other Study ID Numbers: 16.0462
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy