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临床试验/CTRI/2025/07/090335
CTRI/2025/07/090335尚未招募2/3 期

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.

All India Institute Of Medical Sciences Raipur1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年7月24日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Palakjeet Kaur Rissam

AIIMS RAIPUR

研究点 (1)

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