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Root Coverage Using a Xenograph for Treatment of Gingival Recession

Primary Purpose

Localized Gingival Recession

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PriMatrix
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Gingival Recession

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

  • 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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PriMatrix

Arm Description

Use of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Periodontal Parameters
Determine keratinized tissue width of the augmented region using a UNC-15 mm periodontal probe.
Clinical Periodontal Parameters
Determine periodontal probing depths of the augmented region using a UNC-15 mm periodontal probe.
Clinical Periodontal Parameters
Determine tissue thickness of the augmented region using a UNC-15 mm periodontal probe.
Clinical Periodontal Parameters
Determine clinical attachment levels of the augmented region using a UNC-15 mm periodontal probe.
Pain Levels
Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.
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.
Gingival Health
Gingival health will be evaluated visually using Silness and Loe Gingival index.
Plaque Levels
Plaque levels will be evaluated using the Quigley and Hein plaque index.
Esthetic Outcomes
Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.

Full Information

First Posted
December 16, 2015
Last Updated
July 21, 2017
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02657395
Brief Title
Root Coverage Using a Xenograph for Treatment of Gingival Recession
Official Title
PriMatrix Utilization to Achieve Dental Root Coverage
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Bovine collagen matrix -PriMatrix
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PriMatrix
Arm Type
Experimental
Arm Description
Use of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage.
Intervention Type
Device
Intervention Name(s)
PriMatrix
Intervention Description
Use of PriMatrix under a coronal positioned flap to obtain root coverage.
Primary Outcome Measure Information:
Title
Complete Root Coverage
Description
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.
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Clinical Periodontal Parameters
Description
Determine keratinized tissue width of the augmented region using a UNC-15 mm periodontal probe.
Time Frame
Baseline, 6-weeks, 4-months, and 6-months
Title
Clinical Periodontal Parameters
Description
Determine periodontal probing depths of the augmented region using a UNC-15 mm periodontal probe.
Time Frame
Baseline, 6-weeks, 4-months, and 6-months
Title
Clinical Periodontal Parameters
Description
Determine tissue thickness of the augmented region using a UNC-15 mm periodontal probe.
Time Frame
Baseline, 6-weeks, 4-months, and 6-months
Title
Clinical Periodontal Parameters
Description
Determine clinical attachment levels of the augmented region using a UNC-15 mm periodontal probe.
Time Frame
Baseline, 6-weeks, 4-months, and 6-months
Title
Pain Levels
Description
Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.
Time Frame
1-week, 2-weeks, 4-weeks, and 6-months
Title
Mean Root Coverage Obtained
Description
Percentage of baseline root coverage obtained as a fraction of initial recession depth will be measured using a UNC-15 mm periodontal probe.
Time Frame
Baseline, 6-weeks, 4-months, and 6-months
Title
Gingival Health
Description
Gingival health will be evaluated visually using Silness and Loe Gingival index.
Time Frame
Baseline, 6-weeks, 4-months, and 6-months
Title
Plaque Levels
Description
Plaque levels will be evaluated using the Quigley and Hein plaque index.
Time Frame
Baseline, 6-weeks, 4-months, and 6-months
Title
Esthetic Outcomes
Description
Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.
Time Frame
1-week, 2-weeks, 4-weeks, and 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Assad, DDS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Root Coverage Using a Xenograph for Treatment of Gingival Recession

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