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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gingival Diseases

Intervention / Treatment
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* Device: Xenogeneic Collagen Matrix
* Device: Free Gingival Graft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: xenogeneic collagen matrix<br>Xenogeneic collagen matrix device placed on treatment wound bed site | Device: Xenogeneic Collagen Matrix<br>* A type I and III porcine collagen matrix, as cleared by FDA (K012423)<br>|
| Active Comparator: Free Gingival Graft<br>Traditional free gingival graft (autogenous graft device harvested from patient's palate) placed on treatment site wound bed | Device: Free Gingival Graft<br>* Autogenous, full-thickness soft tissue graft harvested from patient's palate.<br>* Other names: Free Autogenous Graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratinized Tissue Width | Change in Keratinized Tissue width | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous; Collagen Matrix; Keratinized Tissue