Postoperative Symptoms Following Endodontic Microsurgery Performed by Piezoelectric Osteotomy Versus Conventional Osteotomy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- changes in pain severity
研究概览
简要总结
Aims: The purpose of this randomized clinical trial is to assess and compare the post operative pain, swelling and quality of life after endodontic microsurgery using either conventional osteotomy or piezoelectric osteotomy . The PICO question that will be used is Does endodontic microsurgery using piezoelectric osteotomy have similar clinical performance in terms of post operative pain and swelling to that of endodontic microsurgery using conventional hand-piece osteotomy.
Material and methods:
based on solid inclusion criteria , a total of 44 patients in need of endodontic microsurgery will be randomly distributed into two groups (n=22) according to the osteotomy technique: conventional and piezoelectric osteotomy. A standardized microsurgical technique will be employed. After the microsurgery procedure, a pain questionnaire that contain visual analogue scale will be given to each patient to evaluate the pain incidence and intensity at 5 time intervals, 24 hours, 48 hours, 72 hours, 96 hours and 120 hours. The patients will be recalled as well, at days 2 and 7 to evaluate the swelling. Statistical analysis will be performed using chi-square test and linear regression analysis.
详细描述
This randomized prospective clinical study will be conducted at the postgraduate clinics, Department of Conservative Dentistry, at Jordan University of Science and Technology.
Ethical approval will be sought from the JUST Institutional ethics and human Research Board (IRB) committee.
Sample size and randomization A total of 44 adult patients will be recruited for this clinical trial. Participants will be randomly allocated to one of the two treatment modalities. Randomization will be carried out by sealed envelope online software.
For the observational part of the study, no randomization or blinding will be applied. Patients will be treated free of charge and their travel expenses will be compensated for all follow up visits.
Preoperative management :
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers .
- •Teeth that are periodontally healthy.
- •Age (18-65)
排除标准
- •Patients with an active systematic diseases that may affect the outcome
- •Medically compromised patients on long term medications.
- •Patients who had received analgesics or antibiotics prior to surgery will be postponed.
- •Cases where orthograde endodontic treatment is feasible
- •Teeth with poor prognosis.
- •Teeth with an active periodontal disease (pocket depth > 5 mm).
- •Emotionally distressed patients.
结局指标
主要结局
changes in pain severity
时间窗: to measure changes in the pain severity at 3 hours, 24 hours , 48 hours , 72 hours and 120 hours.
visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),
Swelling size changes
时间窗: At the second and seventh days after the microsurgery, patients will be re-called for the determination of edema and swelling
Changes in amount of swelling will be measured by measuring distance between fixed points in patient face.
次要结局
未报告次要终点
研究者
Lama Awawdeh
Professor
King Abdullah University Hospital