Buccal Strip Gingival Graft With a Xenogeneic Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites: A Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Sites showing KM≥ 2 mm and AM≥ 1 mm
研究概览
简要总结
The study aims at comparing two different approaches for soft tissue augmentation at implants lacking keratinized and adherent mucosa width: the free gingival graft (FGG) vs the Buccal Strip Graft in combination with a xenogeneic collagen matrix (BSG + CM)
详细描述
Conventional free gingival graft (FGG), serving as control group, will be compared to buccal strip gingival graft (BSG) in combination with a collagen matrix (CM), serving as test group, in terms of clinical, volumetric, ultrasonographic, and patient-reported outcomes related to soft tissue augmentation at implant sites lacking keratinized and adherent mucosa.
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
- 是
入选标准
- •Age ≥ 18 years,
- •Periodontally and systemically healthy,
- •Full-mouth plaque score and full-mouth bleeding ≤ 20% (measured at four sites per tooth),
- •Presence of at least one dental implant with < 2 mm of KM and lack of firm/adherent mucosa,
- •Presence of at least 4 mm of keratinized gingiva in two or more teeth nonadjacent to the implant to be treated,
- •Implants diagnosed as healthy (Berglundh et al. 2018),
- •The patient must be able to perform good oral hygiene.
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),
- •Allergy to collagen-based medical products or iodine,
- •Previous free gingival graft procedure at the target site.
结局指标
主要结局
Sites showing KM≥ 2 mm and AM≥ 1 mm
时间窗: 6 and 12 months
Number of sites showing at least 2 mm of keratinized mucosa width (in millimeters) and at least of 1 mm of attached mucosa (in millimeters) (outcome expressed as a number)
次要结局
- Volumetric change(6 and 12 months)
- KM width gain(6 and 12 months)
- Esthetic assessment(Baseline and 12 months)
- Post-operative morbidity(Daily, for the first 4 weeks after the procedure)
- Ultrasonographic strain elastography(Baseline, 3 months, 6 months and 12 months)
- AM gain(6 and 12 months)
- Ultrasonographic tissue perfusion(Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months)
- Treatment satisfaction(12 months)
- Mucosal thickness (MT) gain(6 and 12 months)
研究者
Lorenzo Tavelli
Assistant Professor
Harvard Medical School (HMS and HSDM)