Tunnel With and Without Intramucosal Vertical Incisions

NCT02486991 | Completed Phase 4 DMC

• 1 other identifier: 15.0532
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Thirty patients will be treated: 15 with a coronally positioned tunnel technique plus intramucosal verticals with AlloDerm® (test treatment) and 15 with a coronally positioned tunnel technique alone with AlloDerm® (control treatment). The surgical procedure for the control sites will consist of a coronally positioned tunnel preparation that is a modification of a previous tunnel technique described by Allen AL (Allen AL, 1994a/1994b). This tunnel technique was modified to include coronal positioning of the soft tissue over an allograft (E.P Allen). The surgical procedure for the test sites will consist of a coronally positioned tunnel preparation (E.P. Allen) plus the use of mesial and/or distal intramucosal verticals, a modification of the vestibular incision subperiosteal tunnel access (VISTA) approach (Zadeh H, 2011). 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. Three exams for measurements will be performed per patient on total: preoperative, at week eight and 16 (4 months) postoperatively. The primary aim is to compare the percent root coverage obtained with acellular dermal matrix using the coronally positioned tunnel technique alone or with intramucosal verticals.

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 alone with acellular dermal matrix (AlloDerm®).

Procedure: Tunnel + AlloDerm®

Tunnel + AlloDerm® + Verticals

EXPERIMENTAL

The use of intramucosal vertical incisions in addition to a coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®).

Procedure: Tunnel + AlloDerm®; Procedure: Tunnel + AlloDerm® + Verticals

Interventions

Tunnel + AlloDerm® PROCEDURE

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

Tunnel + AlloDerm®; Tunnel + AlloDerm® + Verticals

Tunnel + AlloDerm® + Verticals PROCEDURE

The use of intramucosal vertical incisions in addition to a coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®).

Tunnel + AlloDerm® + Verticals

Eligibility Criteria

• Age: 18 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

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: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director-Graduate Periodontics Program

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: July 1, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12