Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Quality of life assessment
研究概览
简要总结
This study will compare the effect of piezo Vs bur on quality of life and healing after endodontic surgery.
详细描述
The goal of endodontic surgery has changed from mere reduction of periapical pathosis and preservation of periodontium to successful postoperative management of patient regarding function and esthetics, improving the quality of life of patient and their overall acceptance. Piezoelectric bone surgery is a recent and innovative technology, permitting selective cutting of mineralized tissues sparing soft tissues.In this study after thorough clinical & radiographic examination patients will be given informed consent after explaining the treatment procedure and its associated risks and benefits. Patients are allocated into 2 groups, group 1(piezo group) in which after flap reflection bone cutting and root end cutting are performed with US6 piezoelectric insert and in group 2(control) bone and root end cutting are performed with conventional bur. Each patient will be given a questionnaire to fill out for each day starting from the day of surgery for 7 days postoperatively to assess the quality of life. They will be also requested to note down the details of analgesic intake. Hemorrhage control during surgery will be assesed. Clinical and radiographic examinations will be performed every 3, 6 and 12 months to evaluate any evidence of signs and/or symptoms and after 12 month follow up post operative CBCT taken to evaluate volume reduction of lesion postoperatively.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with no general medical contra-indications for oral surgical procedures (ASA-1 or ASA-2).
- •Patients of age 16 years and above.
- •The tooth to be treated surgically should have a periradicular lesion of strictly endodontic origin (chronic apical periodontitis).
- •The nonsurgical re-treatment was judged unfeasible or had previously failed.
- •The tooth had an adequate final restoration with no clinical evidence of coronal leakage.
- •The apical area of the root canal should be devoid of the presence of a post for at least 6 mm.
- •Patients with no acute symptoms.
排除标准
- •Unrestorable tooth.
- •Fractured / perforated tooth.
- •Apicomarginal defects.
- •Through & through lesions.
- •Teeth with deep pockets.
- •Serious medical illness(uncontrolled/poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis).
结局指标
主要结局
Quality of life assessment
时间窗: Till 1 week after surgery
By quality of life questionnaire(Igor Tsesis et al)
Postoperative healing
时间窗: 12 months
2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria
次要结局
- hemorrhage control(during surgery)