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Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration

NCT00587834 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2012-11-08

Study results available
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Summary

The purpose of this study is to evaluate Gintuit as a safe and effective alternative to palatal tissue in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingiva associated with at least two nonadjacent teeth.

Conditions

  • Gingival Recession

Interventions

DEVICE

Gintuit

Application of Gintuit at Day 0 to the gingival bed

OTHER

Autologous palatal tissue

Tissue will be harvested from the subject's palate and placed on the gingival bed

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Michael McGuire, DDS · Perio Health Professionals, PLLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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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 NCT00587834 on ClinicalTrials.gov