Root Coverage Using a Xenograph for Treatment of Gingival Recession
PriMatrix Utilization to Achieve Dental Root Coverage
1 other identifier
interventional
12
1 country
1
Brief Summary
Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 25, 2017
July 1, 2017
1.7 years
December 16, 2015
July 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6-months
Secondary Outcomes (9)
Clinical Periodontal Parameters
Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Baseline, 6-weeks, 4-months, and 6-months
Clinical Periodontal Parameters
Baseline, 6-weeks, 4-months, and 6-months
Pain Levels
1-week, 2-weeks, 4-weeks, and 6-months
- +4 more secondary outcomes
Study Arms (1)
PriMatrix
EXPERIMENTALUse of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Assad, DDS
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
December 16, 2015
First Posted
January 15, 2016
Study Start
October 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
July 25, 2017
Record last verified: 2017-07