Clinical Trial: Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Controlled Clinical Trial to Evaluate a Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation

Brief Summary: A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (< 2mm) KT.

Detailed Summary: A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (< 2mm). The study utilized a within subject treatment comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. Patient reported pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at 6-months.
Sponsor: Perio Health Professionals, PLLC

Current Primary Outcome: Keratinized Tissue Width [ Time Frame: 6 months ]

Change in Keratinized Tissue width


Original Primary Outcome: Keratinized Tissue Width [ Time Frame: 6 months ]

Change in KT


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Perio Health Professionals, PLLC

Dates:
Date Received: September 24, 2013
Date Started: November 2010
Date Completion:
Last Updated: May 24, 2014
Last Verified: May 2014