Clinical trial NCT02657395: Root Coverage Using a Xenograph for Treatment of Gingival Recession
Official title: PriMatrix Utilization to Achieve Dental Root Coverage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Localized Gingival Recession
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Bovine collagen matrix -PriMatrix
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete Root Coverage
timeFrame: 6-months
Secondary outcomes:
measure: Clinical Periodontal Parameters
timeFrame: Baseline, 6-weeks, 4-months, and 6-months
measure: Clinical Periodontal Parameters
timeFrame: Baseline, 6-weeks, 4-months, and 6-months
measure: Clinical Periodontal Parameters
timeFrame: Baseline, 6-weeks, 4-months, and 6-months
measure: Clinical Periodontal Parameters
timeFrame: Baseline, 6-weeks, 4-months, and 6-months
measure: Pain Levels
timeFrame: 1-week, 2-weeks, 4-weeks, and 6-months
measure: Mean Root Coverage Obtained
timeFrame: Baseline, 6-weeks, 4-months, and 6-months
measure: Gingival Health
timeFrame: Baseline, 6-weeks, 4-months, and 6-months
measure: Plaque Levels
timeFrame: Baseline, 6-weeks, 4-months, and 6-months
measure: Esthetic Outcomes
timeFrame: 1-week, 2-weeks, 4-weeks, and 6-months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Daniel Assad, DDS
role: PRINCIPAL_INVESTIGATOR
References: