Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT02657395
Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.
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Notify Me18 year–90 year
All sexes
Interventional
Phase 1
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Use of PriMatrix under a coronal positioned flap to obtain 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.
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.
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.
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Determine tissue thickness of the augmented region using a UNC-15 mm periodontal probe.
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.
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.
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.
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Gingival health will be evaluated visually using Silness and Loe Gingival index.
Time frame: Baseline, 6-weeks, 4-months, and 6-months
Plaque levels will be evaluated using the Quigley and Hein plaque index.
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.
Mayo Clinic
Other
PriMatrix Utilization to Achieve Dental Root Coverage
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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