Thick vs. Thin Acellular Dermal Matrix (ADM)

Gingival Recession Clinical Trial

— ADM  

Official title:

Root Coverage Using the Coronally Positioned Tunnel Technique Comparing Thick Versus Thin Acellular Dermal Matrix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392038
• Other study ID #: 16.0462
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: August 21, 2018

Study information

• Verified date: September 2020
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 21, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Thin ADM
Use of soft tissue allograft for root coverage
• Thick ADM
Periodontal surgical procedure to coronally position the tissue over the ADM allograft

Locations

Country	Name	City	State
United States	Graduate Periodontics, UofL School of Dentistry	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent root coverage	Between 0 and 100%	Six months
Secondary	Creeping Attachment	Amount in millimeters	Six months