ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03392038
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

December 31, 2017
January 5, 2018
January 5, 2018
August 1, 2017
June 30, 2018   (Final data collection date for primary outcome measure)
Percent root coverage [ Time Frame: Six months ]
Between 0 and 100%
Same as current
No Changes Posted
Creeping Attachment [ Time Frame: Six months ]
Amount in millimeters
Same as current
Not Provided
Not Provided
 
Thick vs. Thin Acellular Dermal Matrix (ADM)
Root Coverage Using the Coronally Positioned Tunnel Technique Comparing Thick Versus Thin Acellular Dermal Matrix
To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Gingival Recession
  • Procedure: Thin ADM
    Use of soft tissue allograft for root coverage
    Other Name: Thin acellular dermal matrix (ADM GBR)
  • Procedure: Thick ADM
    Periodontal surgical procedure to coronally position the tissue over the ADM allograft
    Other Name: Thick acellular dermal matrix graft (ADM)
  • Experimental: Thin ADM
    Periodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR)
    Intervention: Procedure: Thin ADM
  • Active Comparator: Thick ADM
    Periodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM)
    Intervention: Procedure: Thick ADM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
June 30, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Elliott DeWeese, DMD 502-387-5778 etdewe02@louisville.edu
United States
 
 
NCT03392038
16.0462
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Henry Greenwell, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Henry Greenwell University of Louisville
University of Louisville
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP