Use of a Collagen Membrane for Soft Tissue Grafting

NCT ID: NCT02206009

Last Updated: 2016-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Localized Gingival Recession

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Collagen membrane

First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.

Group Type: EXPERIMENTAL

Collagen Membrane

Intervention Type: DEVICE

First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.

Interventions

Collagen Membrane

First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.

Intervention Type: DEVICE

Other Intervention Names

PriMatrix

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lauren M. F. Syrowik

OTHER

Sponsor Role: lead

Responsible Party

Lauren M. F. Syrowik

DDS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel Assad, DDS

Role: STUDY_DIRECTOR

Mayo Clinic

Lauren MF Syrowik, DDS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

14-000767

Identifier Type: -

Identifier Source: org_study_id