A Prospective, Randomized Clinical Trial to Compare Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access Procedures With Coronally Advanced Flap and Acellular Dermal Matrix (ADM) to Treat Gingival Recession.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
研究概览
简要总结
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva.
The SAMRI technique described is a novel technique involving a simplified incision and suturing technique and to the investigators' knowledge, this is the first study that seeks to compare this technique to other techniques for differences in clinical outcomes (percentage root coverage, resultant tissue thickness, and width of keratinized tissue) and patient-centered outcomes (post-operative pain, swelling, changes in daily activities, and patient-assessed esthetics) in a controlled study.
详细描述
Research data and daily clinical observations reveal that teeth with gingival recession and a lack of adequate keratinized tissue (KT) are more prone to persistent gingival inflammation, dentinal sensitivity, radicular (root) caries (tooth decay), faster periodontal attachment loss, and compromised plaque control. Soft tissue grating (by various techniques) aims at changing the quality, quantity and placement of the soft tissue around teeth by covering exposed root surfaces and creating or increasing the zone of keratinized mucosa (KM) surrounding the affected teeth. Both techniques tested have shown good clinical outcomes with regard to root coverage, but clinical reports suggest that decreased intrasurgical time and the simplified protocol of the SAMRI technique may result in improved clinical outcomes and/or a decrease in postoperative morbidity and complications as assessed by patients.
Specific aims for this project include the evaluation of:
- Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
- KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM
- Change in tissue thickness of the grafted sites at 6 and 12 months
- Practitioner-assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
- Patient-assessed esthetic outcomes at 6 and 12 months post-operatively
- Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •At least 18 years old
- •Must be a patient of the UAB Dental School
- •Able to read and understand informed consent document
- •One or more adjacent teeth (up to four) with Miller class I or II gingival recession defects and less than or equal to 2mm of KT at each site to be treated.
- •Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
- •No anticipated need for restorative care at the teeth to be treated during the study period.
排除标准
- •Non-English speaking
- •Less than 18 years old
- •Smokers/tobacco users (>10 cigarettes/day)
- •Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- •Presence of active periodontal disease or radiographic interproximal bone loss or tooth malposition, which would yield a Miller class III or IV categorization for the recession defect.
- •Presence of frenulae or other soft tissue anomalies at the site(s) to be treated that, in the opinion of the investigators, will interfere with successful access and treatment of the soft tissue defects.
- •Previous soft tissue grafting at the site(s) to be treated
结局指标
主要结局
Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
时间窗: From baseline to 6 months and 12 months
Compare the change in the exposed root surface at sites with gingival recession.
次要结局
- Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively(1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively.)
- Assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively(From baseline to 6 and 12 months)
- KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM(From baseline to 6 and 12 months)
- Change in tissue thickness of the grafted sites at 6 and 12 months(From baseline to 6 and 12 months)
- Assessed esthetic outcomes at 6 and 12 months post-operatively(At 6 and 12 months postoperatively)
研究者
Maria L. Geisinger, DDS, MS
Principal Investigator
University of Alabama at Birmingham