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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

Tracking Information
First Submitted Date  ICMJE December 16, 2015
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date July 25, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02657395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Gingival Health [ Time Frame: Baseline, 6-weeks, 4-months, and 6-months ]
    Gingival health will be evaluated visually using Silness and Loe Gingival index.
  • Plaque Levels [ Time Frame: Baseline, 6-weeks, 4-months, and 6-months ]
    Plaque levels will be evaluated using the Quigley and Hein plaque index.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Root Coverage Using a Xenograph for Treatment of Gingival Recession
Official Title  ICMJE PriMatrix Utilization to Achieve Dental Root Coverage
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Bovine collagen matrix -PriMatrix
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Localized Gingival Recession
Intervention  ICMJE Device: PriMatrix
Use of PriMatrix under a coronal positioned flap to obtain root coverage.
Study Arms  ICMJE Experimental: PriMatrix
Use of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage.
Intervention: Device: PriMatrix
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
20
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657395
Other Study ID Numbers  ICMJE 15-006568
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Daniel Assad, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Assad, DDS Mayo Clinic
PRS Account Mayo Clinic
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP