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

Not Applicable

Completed

• Conditions: Gingival Diseases
• Interventions: Device: Xenogeneic Collagen Matrix; Device: Free Gingival Graft

• Registration Number: NCT01952301
• Lead Sponsor: Perio Health Professionals, PLLC

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 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.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-10
• Study Completion: 2012-01
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-09-27
• Results First Submitted: 2014-01-28
• Results First Submitted QC: 2014-04-16
• Status Verified: 2014-05
• Results First Posted: 2014-05-15
• Last Update Submitted: 2014-05-24
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• At least two non-adjacent teeth in contralateral quadrants of the same jaw with < 2mm of KT that requires soft tissue grafting (1-4 teeth may be treated). In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). The number of teeth treated must be the same on the test and control sites.

  • Root coverage is not desired at the time of grafting.
  • Females of childbearing potential must have a documented negative urine pregnancy test.
  • Read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
  • Able and willing to follow study procedures and instructions.
  • Multi-rooted teeth may be treated but will not be included as study teeth

Exclusion Criteria

• Vestibule depth of less than 7mm from base of recession, and/or teeth with Miller Grade 2 or higher mobility.

  • Any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude periodontal surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
  • Presence of acute infectious lesions in the areas intended for surgery.
  • History of any tobacco use within the last six months.
  • Taking intramuscular or intravenous bisphosphonates.
  • Known hypersensitivity to collagen products, and/or allergy to iodine or shellfish.
  • Participating in other clinical studies involving therapeutic intervention (either medical or dental).
  • Previously undergone a gingival grafting procedure on the test or control teeth or the teeth adjacent to the study site.
  • Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration following entrance into the study.
  • Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
xenogeneic collagen matrix	Xenogeneic Collagen Matrix	Xenogeneic collagen matrix device placed on treatment wound bed site
Free Gingival Graft	Free Gingival Graft	Traditional free gingival graft (autogenous graft device harvested from patient's palate) placed on treatment site wound bed

Primary Outcome Measures

Name	Time	Method
Keratinized Tissue Width	6 months	Change in Keratinized Tissue width