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Clinical Trials/NCT02206009
NCT02206009CompletedPhase 1

PriMatrix Dermal Repair Scaffold Utilization Intraorally

Lauren M. F. Syrowik2 sites in 1 country8 target enrollmentStarted: July 2014Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
8
Locations
2
Primary Endpoint
Change in depth of keratinized tissue

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in depth of keratinized tissue

Time Frame: baseline, approximately 6 months after the procedure

The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Lauren M. F. Syrowik
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Lauren M. F. Syrowik

DDS

Mayo Clinic

Study Sites (2)

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