Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA): A Randomized Clinical Trial With 3D Volumetric Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Areal Marginal Soft Tissue Thickness (aTHK)
研究概览
简要总结
This randomized clinical trial will compare two surgical methods for treating multiple adjacent gingival recessions (types RT1 and RT2): the Modified Coronally Advanced Tunnel (MCAT) and the Vestibular Incision Subperiosteal Tunnel Access (VISTA). Both methods will use connective tissue grafts (CTG), which are the best way to cover roots.
The main objective is to use three-dimensional (3D) digital volumetric analysis to look at how the thickness of soft tissue has changed after six and 12 months. Secondary outcomes include root coverage, esthetic outcomes, gingival health parameters, hypersensitivity, patient satisfaction, and wound healing quality.
There will be 44 volunteers, and they will be randomly assigned to one of the two surgical methods. Under the same settings, periodontal specialists in training will undertake the procedures at the Universidad Complutense de Madrid. There will be follow-up evaluations at different times up to 12 months after the procedure. The results of this study will help determine whether remote incisions via the VISTA technique offer improved outcomes compared to the MCAT technique.
详细描述
Parallel group, clinical evaluator and statistician blinded, randomized clinical trial.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontally and systemically healthy adults (age ≥ 18 years).
- •At least two adjacent sites exhibiting gingival recessions classified as recession type 1 (RT1) o type 2 (RT2) (Cairo et al., 2011), associated with dental hypersensitivity or aesthetic concerns.
- •Presence ≥2 mm depth on at least one recession
- •Smokers ≤ 10 cigarettes.
- •Full-mouth plaque and bleeding scores ≤20%.
- •Patients being able to maintain good oral hygiene.
排除标准
- •Compromised general health.
- •Pregnancy or attempting to get pregnant (self-reported).
- •Untreated periodontal diseases
- •Presence of: (i) severe tooth malposition; (ii) root caries or inadequate prosthetic restorations; (iii) previous periodontal plastic surgery at the experimental sites.
- •Smokers >10 cigarettes
研究组 & 干预措施
Arm 1 : Vestibular Incision Subperiosteal Tunnel Access (VISTA)
Patients in this arm will receive the Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique, involving remote vestibular incisions and subperiosteal tunneling to treat multiple gingival recessions. A connective tissue graft (CTG) will be inserted and stabilized using a coronally anchored suturing technique.
干预措施: Vestibular Incision Subperiosteal Tunnel Access (VISTA) (Procedure)
Arm 2 : Modified Coronally Advanced Tunnel Technique (MCAT)
干预措施: Modified Coronally Advanced Tunnel (MCAT) (Procedure)
结局指标
主要结局
Areal Marginal Soft Tissue Thickness (aTHK)
时间窗: Baseline, 3, 6 and 12 months post-surgery
Soft tissue thickness will be measured using volumetric analysis of STL digital intraoral scans. The region of interest (ROI) corresponds to the previously exposed root surface. The volume difference between baseline and follow-up scans (6 months) will be divided by the surface area leading to an areal thickness (aTHK), expressed in millimeters.
次要结局
- Mean Root coverage(3, 6 and 12 months)
- Recession Depth(Baseline, 3 , 6 and 12 months)
- Probing Pocket Depth(baseline, 3, 6 and 12 months.)
- Keratinized tissue Width(baseline, 3, 6 and 12 months.)
- Gingival Thickness(baseline, 3, 6 and 12 months.)
- Loss of Attachment(Baseline, 3, 6 and 12 months.)
- Root Coverage Esthetic Score(3 6 and 12 months.)
- Dental Hypersensitivity(baseline, 3, 6 and 12 months)
- Flap Tension(Baseline)
- Oral Health Impact Profile(Baseline, 3 6 and 12 month)
- Patients Concerns with recession(Baseline, 6 and 12 month)
- Time to recovery(from baseline to 14 days post surgery)
- Digital recession depth(Baseline, 3 6 and 12 month)
- Digital Complete root coverage(Baseline, 3 6 and 12 month)
- Digital Percentage of root coverage(Baseline, 3 6 and 12 month)
- Digital Pointwise Marginal Soft Tissue Thickness(Baseline, 3 6 and 12 month)
- Surgery duration(During Surgery)
- Full mouth plaque Score(Baseline 3 6 and 12 months)
- Full mouth bleeding Score(Baseline, 3 6 and 12 month)
- Wound Healing Index(Day 7, week 2 , Week 4 and 3 months)
- Modified Coronally advanced tunnel Difficulty score (MCATDS) for the treatment of gingival recessions(Baseline)