Xenogenous Collagen Matrix Graft Associated or Not With Enamel Matrix Derivative Proteins in the Treatment of Gingival Recession Class I and II of Miller: Randomized Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Recession Reduction
研究概览
简要总结
The purpose of this study is to evaluate the reduction of gingival recession of single Miller Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen matrix graft and / or enamel matrix proteins.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Presence of at least one Class I or II Miller gingival recession ≥ 2.5 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (< 0.5 mm): A +(Pini-Prato et al. 2010).
- •Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
- •Full-mouth visible plaque index ≤ 20% (Ainamo & Bay 1975).
- •Full-mouth sulcus bleeding index ≤ 20% (Mühlemann & Son 1971).
排除标准
- •Pregnancy.
- •Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
- •Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
- •Previous periodontal surgery in the area.
研究组 & 干预措施
CAF+MC+EMD
Coronally Advanced Flap with Mucograft and Emdogain
干预措施: Mucograft (Device)
CAF+MC+EMD
Coronally Advanced Flap with Mucograft and Emdogain
干预措施: Coronally Advanced flap (Procedure)
CAF+MC
Coronally Advanced Flap with Mucograft
干预措施: Mucograft (Device)
CAF+MC
Coronally Advanced Flap with Mucograft
干预措施: Coronally Advanced flap (Procedure)
CAF+EMD
Coronally Advanced Flap with Emdogain
干预措施: Coronally Advanced flap (Procedure)
CAF
Coronally Advanced Flap alone
干预措施: Coronally Advanced flap (Procedure)
CAF+EMD
Coronally Advanced Flap with Emdogain
干预措施: Emdogain (Device)
CAF+MC+EMD
Coronally Advanced Flap with Mucograft and Emdogain
干预措施: Emdogain (Device)
结局指标
主要结局
Recession Reduction
时间窗: 6 months
Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.
次要结局
- Complete root coverage(6 months)
研究者
Enilson Antonio Sallum
Professor. Department of Periodontics. Piracicaba Dental School. State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil.
University of Campinas, Brazil