Root Coverage Using a Xenograph for Treatment of Gingival Recession



Status:Recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 90
Updated:7/30/2016
Start Date:October 2015
End Date:June 2017
Contact:Jason M Naud, DDS
Email:naud.jason@mayo.edu
Phone:507-482-4472

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PriMatrix Utilization to Achieve Dental Root Coverage

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

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.

- Inclusion Criteria:

- Adults 18-90 years of age

- Miller Class I & II defects on maxillary or mandibular teeth

- At least 1 adjacent non-involved tooth on either side of the included recession
defects

- Keratinized tissue width of ≥2.0 mm

- Periodontal probing depths of 3 mm or on included teeth

- Plaque index of 2 or less

- Bleeding on probing at 30% or less sites

- Current non-smoker

- No active infected wounds

- Exclusion Criteria

- Patients less than 18 years of age

- Miller Class III, or IV mucogingival defects

- Miller Class I & II defects without adjacent non-involved teeth

- CEJ not identifiable

- Root surface restoration at the defect site

- Periodontal probing depths greater than 3 mm

- Plaque index of 2 or greater

- Bleeding on probing at more than 30% of sites

- Uncontrolled oral disease

- Moderate to severe generalized chronic or aggressive periodontitis

- Oral manifestations of a systemic disease

- History of previous root coverage procedure, graft, or GTR

- Current smoker or other tobacco use

- Alcohol abuse problems

- Traumatic occlusion impinging on the recession defect

- Use of intraoral appliances that impinge on the recession defect

- Intra-oral piercings that impinge on the included defect

- Uncontrolled systemic health conditions

- Debilitating systemic or infectious disease

- Diabetes

- Heart Disease

- Uncontrolled heart disease

- Delayed wound healing

- Immunocompromised status due to medication or immune system dysfunction

- Active infection or non-healing wounds

- Currently pregnant or lactating

- Long-term steroid use
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Daniel Assad, DDS
Phone: 507-284-4472
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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