PriMatrix Utilization to Achieve Dental Root Coverage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Complete Root Coverage
研究概览
简要总结
Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
PriMatrix
Use of PriMatrix as a substitute for a subepithelial connective tissue graft under a coronal positioned flap for root coverage.
干预措施: PriMatrix (Device)
结局指标
主要结局
Complete Root Coverage
时间窗: 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.
次要结局
- Mean Root Coverage Obtained(Baseline, 6-weeks, 4-months, and 6-months)
- Esthetic Outcomes(1-week, 2-weeks, 4-weeks, and 6-months)
- Pain Levels(1-week, 2-weeks, 4-weeks, and 6-months)
- Gingival Health(Baseline, 6-weeks, 4-months, and 6-months)
- Plaque Levels(Baseline, 6-weeks, 4-months, and 6-months)
- Clinical Periodontal Parameters(Baseline, 6-weeks, 4-months, and 6-months)