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Root Coverage Using a Xenograph for Treatment of Gingival Recession

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ClinicalTrials.gov Identifier: NCT02657395
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Assad, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Localized Gingival Recession Device: PriMatrix Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Bovine collagen matrix -PriMatrix
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PriMatrix Utilization to Achieve Dental Root Coverage
Study Start Date : October 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657395


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Daniel Assad, DDS Mayo Clinic

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Responsible Party: Daniel Assad, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02657395     History of Changes
Other Study ID Numbers: 15-006568
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy