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Tunnel With and Without Intramucosal Vertical Incisions

NCT02486991 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-12-08

No results posted yet for this study

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

Interventions

PROCEDURE

Tunnel + AlloDerm®

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

PROCEDURE

Tunnel + AlloDerm® + Verticals

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®).

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Henry Greenwell, DMD, MS · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-06-30
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02486991 on ClinicalTrials.gov