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

Gingival Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952301
• Other study ID #: 13562-007
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: May 24, 2014
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: May 2014
• Source: Perio Health Professionals, PLLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Perio Health Professionals, PLLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keratinized Tissue Width	Change in Keratinized Tissue width	6 months	No