Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Horizontal clinical attachment level
研究概览
简要总结
The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).
详细描述
Proximal class-II furcation represents a challeng to periodontal therapy. Studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. Therefore, enamel matrix derivative proteins (EMD) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
- •Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
- •Presence of one proximal class-II furcation presenting probing depth > 4 mm and bleeding on probing ;
- •Good general health;
- •Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;
排除标准
- •Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
- •Have used antibiotics and anti-inflammatories in the last six months;
- •Smoke ≥ 10 cigarettes/day;
- •Pregnant or lactating;
- •Chronic use of medications that may alter the response of periodontal tissues;
- •Indication of antibiotic prophylaxis for dental procedures;
研究组 & 干预措施
Enamel matrix derivative proteins
Open flap debridement to enamel matrix derivative application in proximal class-II furcation.
干预措施: Enamel matrix derivative proteins (Procedure)
Enamel matrix derivative proteins
Open flap debridement to enamel matrix derivative application in proximal class-II furcation.
干预措施: Open Flap debridement (Procedure)
Open Flap Debridement
Open flap debridement in proximal class-II furcation.
干预措施: Open Flap debridement (Procedure)
结局指标
主要结局
Horizontal clinical attachment level
时间窗: 1 year
horizontal component of the defect
次要结局
未报告次要终点
研究者
Mauro Pedrine Santamaria
DDS,MS,PhD
Universidade Estadual Paulista Júlio de Mesquita Filho