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
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 24, 2013
CompletedFirst Posted
Study publicly available on registry
September 27, 2013
CompletedResults Posted
Study results publicly available
May 15, 2014
CompletedJune 9, 2014
May 1, 2014
11 months
September 24, 2013
January 28, 2014
May 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Keratinized Tissue Width
Change in Keratinized Tissue width
6 months
Study Arms (2)
xenogeneic collagen matrix
ACTIVE COMPARATORXenogeneic collagen matrix device placed on treatment wound bed site
Free Gingival Graft
ACTIVE COMPARATORTraditional free gingival graft (autogenous graft device harvested from patient's palate) placed on treatment site wound bed
Interventions
A type I and III porcine collagen matrix, as cleared by FDA (K012423)
Autogenous, full-thickness soft tissue graft harvested from patient's palate.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.
PMID: 24597764DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael K. McGuire
- Organization
- Perio Health Professionals, PLLC
Study Officials
- PRINCIPAL INVESTIGATOR
Michael K McGuire, DDS
Perio Health Professionals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Michael K McGuire DDS
Study Record Dates
First Submitted
September 24, 2013
First Posted
September 27, 2013
Study Start
November 1, 2010
Primary Completion
October 1, 2011
Study Completion
January 1, 2012
Last Updated
June 9, 2014
Results First Posted
May 15, 2014
Record last verified: 2014-05