Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Recession Reduction
研究概览
简要总结
The purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older 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 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.
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
Chair of the Department of Prosthodontics and Periodontics, Division of Periodontics, Piracicaba Dental School
University of Campinas, Brazil