Comparison of Pinhole Surgical Technique and Tunnel Technique for the Treatment of Gingival Recession: A Split Mouth Clinical and Digital Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in gingival thickness
研究概览
简要总结
This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.
详细描述
Each patient will undergo both surgeries on either quadrant; the PST and tunnel technique. The site will be randomized to receive either type of surgeries. Both types of surgeries are considered minimally invasive procedures to obtain root coverage for gingival recession. Both surgeries are clinically utilized in clinical practice and yield comparable results according to the literature, however, No prospective studies are published to compare between the outcomes of both techniques. patients will receive intra oral scan before the surgery and 6 months after the surgery to compare change in root coverage and gingival thickness outcomes between the two techniques. Post operative pain as well as patient satisfaction will be measured by visual analog scale and compared between the two techniques. Patients will be monitored at different time points to asses healing.
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
盲法说明
PI and statistician will be blinded to the type of investigation for
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between 18-75 years old
- •have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm.
- •American Society of Anesthesiology class I and II
- •full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%
排除标准
- •sites of gingival recession around teeth that are non-salvageable
- •presence of any exudate, infection or local inflammation around the area to be grafted
- •pregnant or breastfeeding females
研究组 & 干预措施
Pinhole/Tunnel
Participants will receive Pinhole surgical technique for treatment of soft tissue recession at one side of the mouth and Tunnel technique for treatment of soft tissue recession at the other side of the mouth
干预措施: Pinhole surgical technique and tunnel technique in a split mouth design (Procedure)
结局指标
主要结局
Change in gingival thickness
时间窗: 6 months (pre operative and at the 6-month follow-up visit)
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness.
Change in gingival recession
时间窗: 6 months (pre operative and at the 6-month follow-up visit)
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession.
次要结局
- Change in sulcus probing depth(6 months (pre operative and at the 6-month follow-up visit))
- Change in papillary recession(6 months (pre operative and at the 6-month follow-up visit))
- Change in root coverage(6 months (pre operative and at the 6-month follow-up visit))
- Change in zone of keratinized tissue(6 months (pre operative and at the 6-month follow-up visit))
- Change in bleeding on probing.(6 months (pre operative and at the 6-month follow-up visit))
- Aesthetic satisfaction(1 day)
- Post-operative pain(1 week)
- Change in clinical attachment.(6 months (pre operative and at the 6-month follow-up visit))
研究者
Mohanad Al-Sabbagh
Professor
University of Kentucky