Evaluation of Post-Endodontic Pain Control Using Low- Level Laser Therapy in Comparison to Intra-canal Cryotherapy: a Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Post-endodontic pain
研究概览
简要总结
Statement of the problem: Postoperative pain following endodontic treatment is a common complication that might require analgesics for pain relief. Low-level laser therapy (LLLT) and Intracanal Cryotherapy (ICCT) are both recommended as non-pharmacological and non-invasive treatment modalities for management of painful situations. Aim of the study: This study is conducted to clinically evaluate and compare the effect of both LLLT and ICCT on post-endodontic pain (PEP) over 5 days in molars with symptomatic apical periodontitis (SAP) using visual analog scale (VAS). Materials & Methods: This parallel arm, randomized clinical trial will involve 95 systemically free patients with SAP in molars. The patients will be randomly allocated to 5 equal groups as follows: control (no intervention), placebo (mock laser therapy), LLLT, ICCT and a combination of both. Postoperative pain levels after 6 hrs, 12 hrs, on 2nd day and 5th day are going to be assessed on the VAS and shall be noted. Data collected will be tabulated and statistically analysed.
详细描述
Selection of patients:
Ninty-five patients shall be selected from the regular pool of patients visiting Misr International University Dental Clinic Complex. After application of inclusion and exclusion criteria, preoperative and percussion pain shall be recorded on a 10-cm VAS by the patients. Percussion will be performed by tapping on the occlusal surfaces of the teeth with the back of a mirror handle. It will be assessed prior to the root canal treatment by the operator who shall be performing the root canal treatment. Diagnosis of the tooth as symptomatic apical periodontitis will be done according to the book Cohen's Pathways of the Pulp. Clinical symptoms are going to be defined as follows:
- Severe preoperative pain (VAS >6)
- Severe percussion pain (VAS > 6) Patients with all inclusion criteria will be offered to participate in the study.
Grouping of samples:
Each selected patient will get a unique serial code that is previously distributed among the 5 groups randomly. Nineteen patients in each as follows; Group 1: Control (no intervention), Group 2: Placebo (mock laser therapy), Group 3: LLLT, Group 4: ICCT and Group 5: Combination of both LLLT and ICCT. New patients will be incorporated in the study in place of lost patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients having a molar tooth with symptomatic apical periodontitis indicated for root canal treatment.
- •Systemically free patients. ASA I
- •Teeth with mature apex.
- •Teeth without root resorption.
排除标准
- •Patients with other pulpal diagnoses.
- •Medically compromised patients.
- •Pregnant females.
- •Patients taking analgesics or anti-inflammatory drugs.
结局指标
主要结局
Post-endodontic pain
时间窗: 5 days
Score on Visual Analogue scale, ranging from 1 (No pain) to 10 (Worst pain)
次要结局
未报告次要终点
研究者
Ahmed Adel Ibrahim Khalaf
Assistant Professor
Misr International University