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

September 8, 2020 updated by: Henry Greenwell, University of Louisville

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Graduate Periodontics, UofL School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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 Names:
  • 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 Names:
  • Thick acellular dermal matrix graft (ADM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent root coverage
Time Frame: Six months
Between 0 and 100%
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creeping Attachment
Time Frame: Six months
Amount in millimeters
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Henry Greenwell, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

August 21, 2018

Study Completion (Actual)

August 21, 2018

Study Registration Dates

First Submitted

December 31, 2017

First Submitted That Met QC Criteria

December 31, 2017

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16.0462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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