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Root Coverage Comparing an Allograft to a Bovine Xenograft

Primary Purpose

Gingival Recession

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tunnel + AlloDerm
Tunnel + Novomatrix
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 - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
  • The mucogingival defect must be on a non-molar tooth.
  • Patients must be at least 18 years of age.

Exclusion Criteria:

  • Patients with debilitating systemic or diseases that significantly affect the periodontium.
  • Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
  • Patients requiring antibiotic prophylaxis.
  • Root surface restorations at the site of recession.
  • No detectable CEJ
  • Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
  • Patients who are pregnant or lactating.
  • Patients who use tobacco products (smoking or smokeless tobacco).
  • Patients with alcohol abuse problems.
  • Patients undergoing long-term steroid therapy.
  • History of previous root coverage procedures, graft or GTR, on the test teeth.
  • 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

Active Comparator

Experimental

Arm Label

Tunnel + AlloDerm®

Tunnel + Novomatrix

Arm Description

A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®).

A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).

Outcomes

Primary Outcome Measures

Percent root coverage
Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2016
Last Updated
June 14, 2018
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT02810067
Brief Title
Root Coverage Comparing an Allograft to a Bovine Xenograft
Official Title
Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Donor Materials
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study was dropped and never started.
Study Start Date
June 2016 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

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
Yes

5. Study Description

Brief Summary
Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials
Detailed Description
Thirty patients will be treated: 15 with a coronally positioned tunnel technique with NovaDerm® xenograft using continuous sling suture to secure both the graft and the flap (test treatment) and 15 with a coronally positioned tunnel technique with AlloDerm® allograft using continuous sling suture to secure both the graft and the flap (control treatment). Sutures used for the control group will be Maxon 5-0, 3/8 circle 13 mm needle for both the test and control groups. The coronally positioned tunnel technique was previously described by Edwards Pat Allen (E.P. Allen, Center for Advanced Dental Education, Dallas, Texas; course manual). Each patient will provide at least one Miller Class I or II facial recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either the test or control treatment. Mentor will toss the coin immediately prior to suturing. Patients will be evaluated postoperatively for a period of 4 months. The examiner will be blinded and will not be aware of the patient treatment at any time during the term of the study. Three exams for measurements will be performed per patient on total: preoperative, at week eight and 16 (4 months) postoperatively.

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
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tunnel + AlloDerm®
Arm Type
Active Comparator
Arm Description
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®).
Arm Title
Tunnel + Novomatrix
Arm Type
Experimental
Arm Description
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).
Intervention Type
Procedure
Intervention Name(s)
Tunnel + AlloDerm
Other Intervention Name(s)
AlloDerm®
Intervention Description
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm).
Intervention Type
Procedure
Intervention Name(s)
Tunnel + Novomatrix
Other Intervention Name(s)
Novomatrix
Intervention Description
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).
Primary Outcome Measure Information:
Title
Percent root coverage
Description
Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985). The mucogingival defect must be on a non-molar tooth. Patients must be at least 18 years of age. Exclusion Criteria: Patients with debilitating systemic or diseases that significantly affect the periodontium. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline). Patients requiring antibiotic prophylaxis. Root surface restorations at the site of recession. No detectable CEJ Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces. Patients who are pregnant or lactating. Patients who use tobacco products (smoking or smokeless tobacco). Patients with alcohol abuse problems. Patients undergoing long-term steroid therapy. History of previous root coverage procedures, graft or GTR, on the test teeth. Patients who fail to complete the informed consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Greenwell, DMD, MS
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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Root Coverage Comparing an Allograft to a Bovine Xenograft

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