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OpenTrials
Completed

NCT Number: NCT03392038

Thick vs. Thin Acellular Dermal Matrix (ADM)

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

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Periodontics, UofL School of Dentistry

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thin ADM

Procedure

Use of soft tissue allograft for root coverage

Other names: Thin acellular dermal matrix (ADM GBR)

Thick ADM

Procedure

Periodontal surgical procedure to coronally position the tissue over the ADM allograft

Other names: Thick acellular dermal matrix graft (ADM)

Primary outcomes

  1. Percent root coverage

    Time frame: Six months

    Between 0 and 100%

Secondary outcomes

  1. Creeping Attachment

    Time frame: Six months

    Amount in millimeters

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Acronym: ADM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2018
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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