Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Horizontal clinical attachment level (HCAL)
研究概览
简要总结
This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.
详细描述
Using a split-mouth design, fifteen patients with bilateral class II and III furcation defects were treated with MIST (Test Group) or CST (Control Group). Furcation defects in both groups were filled with anorganic bovine bone (ABB) and enamel matrix derivative (EMD). Patient-centered outcomes including analyses of pain, discomfort, edema, hematoma, root hypersensitivity and daily activities interference were recorded using a Visual Analogue Scale seven days after surgeries. Clinical and radiographic parameters were assessed at baseline and 6 months postoperatively. Data were statistically analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •(I) subjects with a diagnosis of periodontitis; (II) presence of one pair of contralateral mandibular molars with buccal / lingual furcation defects; (III) non-smokers; (IV) plaque index < 20%.
排除标准
- •(I) patients that presented systemic disease; (II) had taken antibiotics in the past 6 months prior to surgery; (III) pregnant women or lactating mothers; (IV) molars with periapical disease; (V) cervical restorations or prosthesis closer than 1 mm to fornix; (VI) lingual furcation defects presenting gingival recession (GR)
结局指标
主要结局
Horizontal clinical attachment level (HCAL)
时间窗: baseline and 6 months after surgical procedure
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.
次要结局
- Probing pocket depth (PPD)(baseline and 6 months)
- Pain Scores on the Visual Analogue Scale(7 days after surgery)
- Discomfort Scores on the Visual Analogue Scale(7 days after surgery)
- Edema Scores on the Visual Analogue Scale(7 days after surgery)
- Hematoma Scores on the Visual Analogue Scale(7 days after surgery)
- Root Hypersensitivity Scores on the Visual Analogue Scale(7 days after surgery)
- Daily Activities Interference Scores on the Visual Analogue Scale(7 days after surgery)
- Vertical clinical attachment level (VCAL)(baseline and 6 months)
- Gingival recession(baseline and 6 months)
研究者
Tulio Bonna Pignaton
Conventional or minimally invasive surgical technique for the treatment of furcation defects using enamel matrix derivative and anorganic bovine bone - a randomized controlled clinical trial.
University of Sao Paulo