Root Coverage Comparing an Allograft to a Bovine Xenograft

NCT02810067 | Withdrawn DMC

• 1 other identifier: 17.0534
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Study Arms (2)

Tunnel + AlloDerm®

ACTIVE COMPARATOR

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

Procedure: Tunnel + AlloDerm

Tunnel + Novomatrix

EXPERIMENTAL

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

Procedure: Tunnel + Novomatrix

Interventions

Tunnel + AlloDerm PROCEDURE

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

Also known as: AlloDerm®

Tunnel + AlloDerm®

Tunnel + Novomatrix PROCEDURE

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

Also known as: Novomatrix

Tunnel + Novomatrix

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Graduate Periodontics, UofL School of Dentistry

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Henry Greenwell, DMD, MS

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director Graduate Periodontics

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)