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Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PriMatrix | Experimental | Use of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PriMatrix | Device | Use of PriMatrix under a coronal positioned flap to obtain root coverage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical Periodontal Parameters |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Assad, DDS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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Bovine collagen matrix -PriMatrix
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Determine periodontal probing depths of the augmented region using a UNC-15 mm periodontal probe.
| Baseline, 6-weeks, 4-months, and 6-months |
| 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 |
| 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 |
| 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 |
| 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 |
| Gingival Health | Gingival health will be evaluated visually using Silness and Loe Gingival index. | Baseline, 6-weeks, 4-months, and 6-months |
| Plaque Levels | Plaque levels will be evaluated using the Quigley and Hein plaque index. | Baseline, 6-weeks, 4-months, and 6-months |
| 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 |