NCT01952301

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Perio Health Professionals, PLLC · Academic / Other
• Sex: All
• Age: 8 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Gingival Diseases

Interventions

Type	Name	Description
DEVICE	Xenogeneic Collagen Matrix	A type I and III porcine collagen matrix, as cleared by FDA (K012423)
DEVICE	Free Gingival Graft	Autogenous, full-thickness soft tissue graft harvested from patient's palate.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-10-01
• Completion: 2012-01-01
• First posted: 2013-09-27
• Last updated: 2014-06-09
• Results posted: 2014-05-15