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临床试验/NCT07771816
NCT07771816Enrolling By Invitation不适用

Impact of Sodium Hypochlorite Irrigation at Different Concentrations, With and Without Cryotherapy, on Post Operative Pain in Permanent Mandibular Molar Teeth "Randomized Controlled Trial"

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
3
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

The aim of the present study will compare the impact of sodium hypochlorite irrigation at different concentrations with and without cryotherapy on post operative pain in permanent mandibular molar teeth.

Will cryotherapy combined with sodium hypochlorite irrigation at different concentrations reduce postoperative pain in compared to conventional sodium hypochlorite irrigation during pulpotomy of mandibular molar teeth with symptomatic irreversible pulpitis?

详细描述

Sodium hypochlorite (NaOCl) is among the most commonly recommended irrigants due to its broad-spectrum antimicrobial effect, ability to dissolve organic tissue, and efficacy in eliminating biofilm(6). However, most of the evidence supporting its use comes from studies in root canal therapy, not vital pulp therapy. NaOCl action in pulpotomy differs significantly because the material comes into direct contact with living, vascularized, sensitive pulp tissue, raising concerns about its potential cytotoxicity

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Eligibility criteria:
  • A- Inclusion criteria:
  • Tooth show positive response to sensitivity test.
  • Haemostasias can be achieved after total pulpotomy.
  • The tooth is restorable and free from advanced periodontal disease, cracks and splits.
  • Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars teeth only will be involved.
  • Patients of either gender aged from 15-
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  • Patients who will agree to the consent and will commit to follow-up period.
  • Patients with mature root.
  • Patients with no internal or external resorption and no periapical lesions.
  • Soft tissues around the tooth are normal with no swelling or sinus tract.

排除标准

  • Patients with immature roots.
  • Haemostasias after 10 minutes can not be controlled after total pulpotomy
  • Patients with any systemic disease that may affect normal healing.
  • Patients with periapical lesions or infections.
  • Pregnant females.
  • Patients who could/would not participate in a 6 months follow-up.
  • Patients with fistula or swelling
  • Patients with necrotic pulp.
  • Patients with old age.

结局指标

主要结局

postoperative pain

时间窗: Pain will be assessed at baseline (preoperatively) and postoperatively at 6 hours, 12 hours , 24 hours , 72 hours and 1week after treatment.

numerical rate scale (NRS), ranging from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain.

次要结局

  • overall success(3 months, 6 months and 12 months after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Mohamed Elsayed Aboelazm

principal investigator

Future University in Egypt

研究点 (1)

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