Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Miller Class I Gingival Recessions: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Recession Reduction as measured by difference between gingival recession depth
研究概览
简要总结
The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients will receive EMD associated to SCPF, while the other half, will receive SCPF alone.
详细描述
The aim of this study will be evaluate clinically the use of the Semilunar Coronally Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel Matrix Derivative (EMD). Thirty patients will be selected, randomized and allocated in two groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated: gingival recession height (GRH), gingival recession width(GRW), clinical attachment level (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be collected at baseline and 180 days after surgery.
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, Investigator)
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 Miller Class I gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ);
- •Height of keratinized tissue ≥ 2 mm;
- •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.
结局指标
主要结局
Change in Recession Reduction as measured by difference between gingival recession depth
时间窗: Baseline, 12 months
Measured as a difference between gingival recession depth at baseline and gingival recession at 6 months follow-up.
次要结局
- Complete root coverage(12 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