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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thin ADM
Thick ADM
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Graduate Periodontics, UofL School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thin ADM

Thick ADM

Arm Description

Periodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR)

Periodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM)

Outcomes

Primary Outcome Measures

Percent root coverage
Between 0 and 100%

Secondary Outcome Measures

Creeping Attachment
Amount in millimeters

Full Information

First Posted
December 31, 2017
Last Updated
September 8, 2020
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03392038
Brief Title
Thick vs. Thin Acellular Dermal Matrix (ADM)
Acronym
ADM
Official Title
Root Coverage Using the Coronally Positioned Tunnel Technique Comparing Thick Versus Thin Acellular Dermal Matrix
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thin ADM
Arm Type
Experimental
Arm Description
Periodontal root coverage surgery using a coronally positioned tunnel and thin acellular dermal matrix (ADM GBR)
Arm Title
Thick ADM
Arm Type
Active Comparator
Arm Description
Periodontal root coverage surgery using coronally positioned tunnel surgery and thick acellular dermal matrix graft (ADM)
Intervention Type
Procedure
Intervention Name(s)
Thin ADM
Other Intervention Name(s)
Thin acellular dermal matrix (ADM GBR)
Intervention Description
Use of soft tissue allograft for root coverage
Intervention Type
Procedure
Intervention Name(s)
Thick ADM
Other Intervention Name(s)
Thick acellular dermal matrix graft (ADM)
Intervention Description
Periodontal surgical procedure to coronally position the tissue over the ADM allograft
Primary Outcome Measure Information:
Title
Percent root coverage
Description
Between 0 and 100%
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Creeping Attachment
Description
Amount in millimeters
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Greenwell
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Periodontics, UofL School of Dentistry
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Thick vs. Thin Acellular Dermal Matrix (ADM)

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