NCT02657395

Root Coverage Using a Xenograph for Treatment of Gingival Recession

PriMatrix Utilization to Achieve Dental Root Coverage

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.

Detailed description

PriMatrix (TEI Medical Inc) is a promising collagen membrane derived from fetal bovine dermis. The acellular porous structure of the membrane permits rapid re-vascularization and cellular re-population. The membrane contains a high proportion of type III collagen. Type III collagen helps regulate tissue healing by promoting neoepithelialization and angiogenesis. Wounds grafted with PriMatrix exhibited significantly faster healing rates compared to control wounds while having a minimal foreign body response and early repopulation by progenitor cells. The ability of PriMatrix to permit neovascularization, reepithelialization, minimal immune response, and population by progenitor cells suggests that it may serve as an ideal alternative to CTG under CPF for root coverage. In this regard, the current study aims to serve as a pilot to test the feasibility of the use of PriMatrix as a graft material under a CPF to attain root coverage of Miller Class I \& II defects.

Conditions

• Localized Gingival Recession

Interventions

Type	Name	Description
DEVICE	PriMatrix	Use of PriMatrix under a coronal positioned flap to obtain root coverage.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-01-15
• Last updated: 2017-07-25

Locations

1 site across 1 country: United States