Root Coverage Using a Xenograph for Treatment of Gingival Recession

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.

Study Overview

• Status: Completed
• Conditions: Localized Gingival Recession
• Intervention / Treatment: Device: PriMatrix

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PriMatrix; Use of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage.	Device: PriMatrix; Use of PriMatrix under a coronal positioned flap to obtain root coverage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Root Coverage	The percentage of sites showing complete root coverage will be calculated as a percent of treated defects with the marginal gingival located at or above the cement-enamel junction compared to the total defects treated.	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Periodontal Parameters	Determine keratinized tissue width of the augmented region using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters	Determine periodontal probing depths of the augmented region using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters	Determine tissue thickness of the augmented region using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters	Determine clinical attachment levels of the augmented region using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Pain Levels	Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.	1-week, 2-weeks, 4-weeks, and 6-months
Mean Root Coverage Obtained	Percentage of baseline root coverage obtained as a fraction of initial recession depth will be measured using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Gingival Health	Gingival health will be evaluated visually using Silness and Loe Gingival index.	Baseline, 6-weeks, 4-months, and 6-months
Plaque Levels	Plaque levels will be evaluated using the Quigley and Hein plaque index.	Baseline, 6-weeks, 4-months, and 6-months
Esthetic Outcomes	Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.	1-week, 2-weeks, 4-weeks, and 6-months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Daniel Assad, DDS, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 15-006568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED