Clinical trial NCT02206009: Use of a Collagen Membrane for Soft Tissue Grafting
Official title: PriMatrix Dermal Repair Scaffold Utilization Intraorally
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Localized Gingival Recession
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depth of keratinized tissue
timeFrame: baseline, approximately 6 months after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Daniel Assad, DDS
role: STUDY_DIRECTOR
affiliation: Mayo Clinic
name: Lauren MF Syrowik, DDS
role: PRINCIPAL_INVESTIGATOR
References: