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Use of a Collagen Membrane for Soft Tissue Grafting

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Localized Gingival Recession

Intervention: Collagen Membrane (Device)

Phase: Phase 1

Status: Recruiting

Sponsored by: Lauren M. F. Syrowik

Official(s) and/or principal investigator(s):
Daniel Assad, DDS, Study Director, Affiliation: Mayo Clinic
Lauren MF Syrowik, DDS, Principal Investigator, Affiliation: Mayo Clinic


Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?

Clinical Details

Official title: PriMatrix Dermal Repair Scaffold Utilization Intraorally

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in depth of keratinized tissue

Detailed description: PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a sheet-like matrix made up primarily of type I and type III collagen. An increased proportion of type III collagen appears to play a key role in healing and regeneration. The use of extracellular dermal matrices is a relatively young field, and the exact mechanism by which PriMatrix promotes skin regeneration is still unknown. Despite this, PriMatrix has demonstrated differences in manufacturing and molecular composition that make it conducive to the harsh environments in which it has already been tested. Intraorally, where there is a rich vascular bed, this material holds exceeding promise. Utilizing this vascularity, autogenous free gingival grafts from the palate have already had their efficacy proven as a method of augmenting the keratinized tissue. The need to increase the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium is more resilient than the non-keratinized oral mucosa. This is especially important in areas where recession and attachment loss has already occurred. Without having keratinized gingiva apical to the recession area, it has been suggested that there is a greater risk for more attachment loss to occur, thus reducing the support for the tooth. In addition, autogenous free gingival grafts have demonstrated the phenomenon of "creeping attachment" where a portion of the recession actually becomes covered as a result of grafting. While autogenous grafting is the gold standard in soft tissue augmentation, the amount of tissue that can be taken from the palate is limited, making it difficult to treat patients with generalized recession. Furthermore, a secondary surgical site increases the morbidity associated with the procedure. The hypothesis of this study is that PriMatrix will be able to provide similar results to an autogenous free gingival graft.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Must have one to three consecutive teeth with recession and less than 1 mm of

keratinized gingiva Exclusion Criteria:

- Asthma

- Pregnancy

- Uncontrolled diabetes

- Use of continuous positive airway pressure (CPAP) machine for sleep apnea

- Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism

splints, etc.)

- Tobacco use

- Immunocompromised individual

Locations and Contacts

Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Lauren Syrowik, DDS, Phone: 507-284-8410, Email: syrowik.lauren@mayo.edu
Additional Information

Starting date: July 2014
Last updated: April 28, 2015

Page last updated: August 20, 2015

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