Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in Soft tissue dehiscence depth
研究概览
简要总结
The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative
详细描述
The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative) when performed for vertical soft tissue augmentation at sites with peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic, and patient-reported outcomes will be evaluated at different time points up to 1 year.
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
- •Age ≥ 18 years
- •Periodontally and systemically healthy
- •Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
- •Presence of single functional dental implant in the anterior with a PSTD
- •Implants diagnosed as healthy (Berglundh et al., 2018)
排除标准
- •Contraindications for surgery
- •Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing
- •Patients pregnant or attempting to get pregnant (self-reported)
- •Untreated periodontitis
- •Untreated peri-implant mucositis or peri-implantitis (Berglundh et al., 2018)
- •Smoking, defined as self-reported daily habit. Occasional smokers won't be excluded
- •History of soft tissue grafting at the implant site within the last 6 months
结局指标
主要结局
Change in Soft tissue dehiscence depth
时间窗: 12 months
Change of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) at 12 months compared to baseline (expressed in millimeters)
次要结局
- Mucosal thickness changes(3, 6, and 12 months)
- Professional esthetic assessment (IDES)(12 months)
- 3D Volumetric changes(3, 6, and 12 months)
- Complete peri-implant soft tissue dehiscence (PSTD) coverage(12 months)
- mean peri-implant soft tissue dehiscence (PSTD) coverage(12 months)
- Post-operative pain(14 days after the surgery)
研究者
Lorenzo Tavelli
Assistant Professor
Harvard Medical School (HMS and HSDM)