Root Coverage Using a Xenograph for Treatment of Gingival Recession

Localized Gingival Recession Clinical Trial

Official title:

PriMatrix Utilization to Achieve Dental Root Coverage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657395
• Other study ID #: 15-006568
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2015
• Last updated: July 21, 2017
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Gingival Recession
• Localized Gingival Recession

Intervention

Device:
• PriMatrix
Use of PriMatrix under a coronal positioned flap to obtain root coverage.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Periodontal Parameters	Determine keratinized tissue width of the augmented region using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Secondary	Clinical Periodontal Parameters	Determine periodontal probing depths of the augmented region using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Secondary	Clinical Periodontal Parameters	Determine tissue thickness of the augmented region using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Secondary	Clinical Periodontal Parameters	Determine clinical attachment levels of the augmented region using a UNC-15 mm periodontal probe.	Baseline, 6-weeks, 4-months, and 6-months
Secondary	Pain Levels	Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.	1-week, 2-weeks, 4-weeks, and 6-months
Secondary	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.	Baseline, 6-weeks, 4-months, and 6-months
Secondary	Gingival Health	Gingival health will be evaluated visually using Silness and Loe Gingival index.	Baseline, 6-weeks, 4-months, and 6-months
Secondary	Plaque Levels	Plaque levels will be evaluated using the Quigley and Hein plaque index.	Baseline, 6-weeks, 4-months, and 6-months
Secondary	Esthetic Outcomes	Visual analog scale questionnaire will be completed consisting of 5 to 6 questions at each appointment.	1-week, 2-weeks, 4-weeks, and 6-months