Impact of Periapical Radiography and Cone Beam Computed Tomography on Periapical Assessment Following Surgical Endodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Postoperative healing
研究概览
简要总结
This study will compare Cone beam Computed Tomography and Periapical radiography in detection and measurement of periapical lesions and healing outcomes following periapical surgery.
详细描述
Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics.
Study Design: - Prospective clinical trial
Time Frame: - Jan 2019 to April 2020
Population / Participants: -Patients of age 18 years and above will be enrolled in the study.
Sample size: - The anticipated change in treatment plan was expected to be 53% before and after using CBCT. Based on the available data , sample size was calculated to enroll a minimum of 18 patients in each group with a power level of 90% and alpha at the 5% level. Considering the dropouts, a total of 50 patients (n=25 each group) will be recruited for the study.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient willingness to participate in the study.
- •Patient's age more than 18 years.
- •Failed root canal treated permanent teeth with post-treatment apical periodontitis requiring treatment.
- •Patients referred for periapical surgery of permanent teeth because of separated instrument fragment, overextended root canal filling material or any other idiopathic reasons.
- •Radiographic evidence of periapical radiolucency in failed root canal treated teeth.
- •American classification of anesthesiologists (ASA) Class I or ASA Class 2 according to ASA classification.
排除标准
- •Positive history of antibiotic use within past three months of the treatment.
- •Positive history of analgesic use within the past 7 days.
- •Procedural errors in previous root canal treatment which are not manageable.
- •Patients who are pregnant, diabetic, having human immunodeficiency virus infection or other immune compromising conditions, had serious medical illness or requiring antibiotic premedication.
- •Patients with unrestorable lesions, fractures involving the root and periodontium, and/or periodontally compromised teeth.
结局指标
主要结局
Postoperative healing
时间窗: 12 months
Radiographic healing will be assessed in periapical radiography and CBCT after 12 months
次要结局
- Quality of life assessment(till 1 wek after surgery)