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OpenTrials
Completed

NCT Number: NCT02657395

Root Coverage Using a Xenograph for Treatment of Gingival Recession

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

PriMatrix

Device

Use of PriMatrix under a coronal positioned flap to obtain root coverage.

Primary outcomes

  1. Complete Root Coverage

    Time frame: 6-months

    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.

Secondary outcomes

  1. Clinical Periodontal Parameters

    Time frame: Baseline, 6-weeks, 4-months, and 6-months

    Determine keratinized tissue width of the augmented region using a UNC-15 mm periodontal probe.

  2. Clinical Periodontal Parameters

    Time frame: Baseline, 6-weeks, 4-months, and 6-months

    Determine periodontal probing depths of the augmented region using a UNC-15 mm periodontal probe.

  3. Clinical Periodontal Parameters

    Time frame: Baseline, 6-weeks, 4-months, and 6-months

    Determine tissue thickness of the augmented region using a UNC-15 mm periodontal probe.

  4. Clinical Periodontal Parameters

    Time frame: Baseline, 6-weeks, 4-months, and 6-months

    Determine clinical attachment levels of the augmented region using a UNC-15 mm periodontal probe.

  5. Pain Levels

    Time frame: 1-week, 2-weeks, 4-weeks, and 6-months

    Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.

  6. Mean Root Coverage Obtained

    Time frame: Baseline, 6-weeks, 4-months, and 6-months

    Percentage of baseline root coverage obtained as a fraction of initial recession depth will be measured using a UNC-15 mm periodontal probe.

  7. Gingival Health

    Time frame: Baseline, 6-weeks, 4-months, and 6-months

    Gingival health will be evaluated visually using Silness and Loe Gingival index.

  8. Plaque Levels

    Time frame: Baseline, 6-weeks, 4-months, and 6-months

    Plaque levels will be evaluated using the Quigley and Hein plaque index.

  9. Esthetic Outcomes

    Time frame: 1-week, 2-weeks, 4-weeks, and 6-months

    Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

PriMatrix Utilization to Achieve Dental Root Coverage

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2016
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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