Comparative evaluation of intracanal Saline as final irrigation at 2-4°C and 13-15°C Versus Room-Temperature on Post-Operative Pain over 48 Hours in Single visit Pulpectomy: A Parallel three arm Randomized Clinical Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- postoperative pain reduction among patients undergoing single-visit pulpectomy
研究概览
简要总结
This randomized, double-blinded clinical trial aims to assess whether using cold saline as a final irrigant during single-visit pulpectomy reduces post-operative pain in children aged 4 to 8 years. The study involves 66 participants divided equally into three groups: one receiving room-temperature saline, and the other two receiving saline cooled to 2–4°C and 13–15°C, respectively. All children undergo standard pulpectomy procedures, including anesthesia, rubber dam isolation, caries removal, canal instrumentation, and irrigation. Final irrigation is performed with 20 ml of saline for 5 minutes, with temperature maintained using thermal flasks and verified with thermometers. To collect pain data, the Wong-Baker Faces Pain Scale is used, which helps children communicate pain intensity by pointing to facial expressions. Each participant’s guardian receives a pain assessment form to record the child’s pain levels at 6, 12, 24, and 48 hours post-operatively. These recordings are confirmed through scheduled video calls with a blinded evaluator to ensure accuracy and reduce recall bias. Additional forms include the patient information sheet, informed consent form, and case record form. The study also tracks whether pain medication was needed. The expected outcome is a reduction in post-operative pain and analgesic requirement in both cryotherapy groups compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)(—)
- 性别
- All
入选标准
- •Children aged 4–8 years requiring pulpectomy in primary molars.
- •Primary molars with irreversible pulpitis both symptomatic and asymptomatic but with restorable crown structure.
- •Roots showing minimal root resorption Medically healthy children ASA Class I with no systemic diseases that could affect pain perception or healing.
- •Children whose parents/guardians are willing to give consent for participation in the study and post operative pain assessment via video calling.
排除标准
- •Primary molars with severe carious destruction, periapical pathology causing extensive bone loss, or furcation involvement.
- •Less than 2/3rd of the root intact.
- •Children with bleeding disorders, special healthcare needs, immunocompromised conditions, or congenital heart diseases requiring antibiotic prophylaxis.
- •Children taking anti-inflammatory or analgesic medications within 24 hours before treatment.
- •• Children with uncooperative behaviour (Frankl’s negative or definitely negative: 1 or 2) that may interfere with the study procedure.
- •• Any known allergy to local anaesthetics, medicaments, or irrigation solutions used in the study.
- •• Children whose parents/guardians are not willing to give consent for participation in the study and post operative pain assessment via video calling.
- •Cases with obturation material extruded beyond the apex.
结局指标
主要结局
postoperative pain reduction among patients undergoing single-visit pulpectomy
时间窗: preoperative, 6, 12, 24,48 hours
using two different cryotherapy temperatures versus room-temperature saline as final
时间窗: preoperative, 6, 12, 24,48 hours
intracanal irrigation
时间窗: preoperative, 6, 12, 24,48 hours
次要结局
- Post operative analgesic requirement(preoperative, 6, 12, 24,48 hours)
研究者
Palakjeet Kaur Rissam
AIIMS RAIPUR
