Effect of Intra-Canal Cryotherapy on Post Operative Pain After Primary and Secondary Root Canal Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative pain assessment using the visual analog scale (VAS)
研究概览
简要总结
The goal of this randomised clinical trial is to evaluate the effect of cryotherapy on postoperative pain after primary and secondary root canal treatment. The main question[s] it aims to answer are:
- Dose cryotherapy help reduce postoperative pain after primary root canal treatment.
- Dose cryotherapy help reduce postoperative pain after secondary root canal treatment.
Participants will be randomly divided to receive either cryotherapy or irrigation with normal saline and the effect between the two groups in terms of postoperative pain will be compared after primary and secondary root canal treatment.
详细描述
Procedure
Previous pain assessment:
Both pre- and postoperative pain will be assessed using Huskinsson's visual analog scale (VAS). According to the quantitative data obtained from the VAS scale, these values are categorized as follows: no pain (0), slight pain (0.1-3.9), moderate pain (4-6.9) or pain severe (7-10).
Informed consent After the procedure is carefully explained to the patient and the patient has accepted the treatment plan and signed the Consent, they will be included in the study. Students will give a complete explanation of the study, the forms of pain and how to properly fill out the pain form. If the patient wishes to participate, they will sign the document in order to continue with the treatment and be included in the study.
Root canal treatment and retreatment Vitality test which includes cold test using Endo Ice (Coltene, Switzerland) and Electrical pulp test (EPT) (Shadental, India) for cases of primary root canal treatment. Vertical and lateral percussion tests, periodontal probing, and periapical and bitewing radiographs will be performed in order to perform the pulpal and periapical diagnosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years.
- •Patients who demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and who received a signed and dated copy of the informed consent form.
- •Patients who understand and are willing to comply with all study procedures and restrictions.
- •Absence of clinically significant and relevant abnormalities in the clinical history or oral examination.
- •Endodontic treatment considered the treatment of choice for both multi and single rooted teeth.
- •Endodontic retreatment considered the treatment of choice only in posterior molar teeth (multirooted).
- •Only one treatment per patient.
排除标准
- •Patients who are allergic to any of the materials used in the treatment.
- •Patients with heart pacemaker.
- •Patients with any general pathology that requires antibiotic prophylaxis.
- •Root resorption, root fractures, impossibility of restoration.
- •Pregnant patients.
- •Patients who took painkillers in the last 6 hours.
- •Case where apical patency couldn't be achieved
- •Cases where final obturation quality is compromised.
- •Any intra operative factor that complication that can compromise the treatment outcome like root perforation or fractured instrument or inability to localize/prepare any canal.
研究组 & 干预措施
Root canal treatment cryotherapy group
Conventional root canal treatment with final irrigation using sterile saline at 2.5ºC
干预措施: cryotherapy with sterile saline at 2.5ºC (Drug)
Root canal RE-treatment cryotherapy group
Conventional root canal RE-treatment with final irrigation using sterile saline at 2.5ºC
干预措施: cryotherapy with sterile saline at 2.5ºC (Drug)
Root canal treatment control group
Conventional root canal treatment with final irrigation using sterile saline at room temperature
干预措施: control with sterile saline at room temperature (Drug)
Root canal RE-treatment control group
Conventional root canal RE-treatment with final irrigation using sterile saline at room temperature
干预措施: control with sterile saline at room temperature (Drug)
结局指标
主要结局
Postoperative pain assessment using the visual analog scale (VAS)
时间窗: Preoperative, 6 hours,12 hours, 24 hours, 48 hours, 72 hours, 5 days and 7 days
Both pre- and postoperative pain will be assessed using the visual analog scale (VAS). According to the quantitative data obtained from the VAS scale (from 1 to 10), these values will be categorized as follows: no pain (0), slight pain (0.1-3.9), moderate pain (4-6.9) or severe pain (7-10)
次要结局
未报告次要终点
研究者
Firas Elmsmari
Principal Investigator
Ajman University