Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Coverage Around Implants: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- mean mid-facial recession coverage (mRC)
研究概览
简要总结
The purpose of this study is to assess the influence of two different flap designs (envelope Coronally Advanced Flap (eCAF) and Modified Tunnel Technique (MTT)) with the addition of a connective tissue graft (CTG) in treating soft tissue dehiscences at implant sites
详细描述
The primary aim is to compare the test and control groups in terms of:
- mean mid-facial recession coverage (mRC) measured as a percentage
- the keratinized tissue (KT) gain measured in mm
- the keratinized tissue thickness (KTT) gain measured in mm.
The secondary aims are to compare the two groups in terms of:
- Esthetic score, using numeric values from 0 to 10
- patient-reported esthetics, using numeric values from 1 to 5
- patient-reported post-operative pain, based on Visual Analog Scale (VAS) scale, measured as numbers from 0 to 10.
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 (Participant, 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
- •Age ≥ 18 years
- •Periodontally and systemically healthy
- •Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
- •Correct implant 3-dimensional position or buccal position ≤ 1 mm
- •Buccal soft tissue dehiscence ≤ 4 mm
- •Only osseointegrated implants
- •The patient must be able to perform good oral hygiene
排除标准
- •Contraindications for periodontal surgery
- •Patients pregnant or attempting to get pregnant
- •Malpositioned implant
- •Soft tissue dehiscence (STD) > 4 mm
- •Multiple adjacent implants with STD
- •Existing of peri-implantitis
- •Severe bone loss (≥4mm)
- •Moderate-severe interproximal bone loss (implant fixture level to the alveolar bone > 3 mm)
- •Moderate-severe papilla height loss (Nordland and Tarnow implant papillae index >1)
- •Previous mucogingival surgery around the implant within the past six months or implant placement at the surgical site less than six months prior
- •Smoking more than 10 cigarettes a day
研究组 & 干预措施
envelope Coronally Advanced Flap (eCAF)
A mucogingival surgery where an envelope flap is coronally advanced and sutured to cover the mucosal recession
干预措施: Mucogingival surgery (Procedure)
Modified Tunnel Technique (MTT)
A mucogingival surgery where the gingiva is released without reflecting a flap (as described for tunnel techniques) and then coronally advanced and sutured to cover the mucosal recession
干预措施: Mucogingival surgery (Procedure)
结局指标
主要结局
mean mid-facial recession coverage (mRC)
时间窗: up to 1 year
mRC measured as a percentage
次要结局
- Esthetic score(6 months and 1 year)
- Patient-reported esthetics(6 months and 1 year)
- Keratinized tissue thickness (KTT)(6 months and 1 year)
- Patient-reported post-operative pain(2 weeks)
- Keratinized tissue (KT) gain(6 months and 1 year)
研究者
Hom-Lay Wang, DDS, MSD, Ph D
Collegiate Professor of Periodontics and Professor of Dentistry
University of Michigan