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临床试验/NCT07764666
NCT07764666Enrolling By Invitation不适用

Compare the Impact of Sodium Hypochlorite and Saline Irrigation Protocols With and Without Cryotherapy on Post-operative Pain Following Pulpotomy in Permanent Mandibular Molar Teeth. "Randomized Controlled Trial"

Abdelrahman Refaat Khalaf Ahmed1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
3
试验地点
1
主要终点
post operative pain

研究概览

简要总结

The aim of the present study will compare the impact of sodium hypochlorite and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.Will the use of sodium hypochlorite and saline irrigation protocols with and without cryotherapy have an effect on post-operative pain and overall success following pulpotomy in permanent mandibular molar compared to normal saline irrigation ?

详细描述

Cryotherapy is another modified technique for pulpotomy,, lowering the temperature of the target tissue will help in eradication or diminishing of the pain experienced by patients in many medical conditions before it was adopted to dental pain cases. Although these theoretical benefits are promising, the clinical evidence directly comparing cryotherapy-assisted irrigation with standard NaOCl or saline protocols in pulpotomy remains limited. Therefore, the present study is to compare the impact of sodium hypochlorite and saline irrigation protocols with and without cryotherapy on post-operative pain following pulpotomy in permanent mandibular molar teeth.

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
是

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.

研究组 & 干预措施

cryotherapy enhanced with saline

Experimental

the intervention group and the pulpotomy irrigation agent will be cryotherapy with saline

干预措施: vital pulp therapy /complete pulpotomy (Procedure)

2.5% NAOCL

Experimental

intervention group and the pulpotomy irrigation agent will be NAOCL2.5%.

干预措施: VPT /pulpotomy (Procedure)

cryotherapy enhanced with 2.5% NAOCL

Experimental

the intervention group and the pulpotomy irrigation agent will be cryotherapy with NAOCL2.5%.

干预措施: VPT/complete pulpotomy (Procedure)

结局指标

主要结局

post operative pain

时间窗: Pain will be recorded preoperative and after 6 hours, 12 hours , 24 hours , 72 hours and 1 week using numerical rate scale (NRS)

Postoperative pain reported by the patient after pulpotomy in groups is to be recorded by NRS (Numerical Rate Scale). Scale from 0-10 recorded every 24hours until the seventh day. The NRS for pain is a straight line with one end (point 0) meaning no pain and the other end (point 10) meaning the worst pain imaginable.

次要结局

  • Clinical and Digital radiograph overall success(3 month ,6 month and 12 month)

研究者

发起方
Abdelrahman Refaat Khalaf Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abdelrahman Refaat Khalaf Ahmed

Postgraduate Researcher, Department of Endodontics

Future University in Egypt

研究点 (1)

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