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临床试验/CTRI/2024/04/065587
CTRI/2024/04/065587已完成Phase 3 4

Evaluation of the effect of intracanal cryotreated sodium hypochlorite on post obturation pain in single visit root canal treatment - A comparative clinical trial

Dr Naveen prasath1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年4月25日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Reduction of post operative pain using cryotreated irrigant after single visit root canal treatment

研究概览

简要总结

AIM

The aim of this in-vivo study is to compare and evaluate the effect of intracanal cryotreated sodium hypochlorite on post obturation pain in single visit root canal treatment with and without the final rinse with cryotreated normal saline.

MATERIALS AND METHODS

A total of 75 patients with symptomatic irreversible pulpitis with normal periapical tissues / symptomatic apical periodontitis in mandibular premolars which require root canal therapy will be randomly selected. Conventional access cavity will be prepared under local anaesthesia and rubber dam isolation, followed by working length determination and cleaning and shaping will be completed using Hyflex CM rotary files upto 30/0.4 size. Copious irrigation with 5.25% NaOCl and 17 % EDTA will be carried out during the use of each file and the irrigants will be activated using endoactivator. After cleaning and shaping, all samples will be randomly divided into 3 groups as per the final irrigation protocol to be followed.

Group 1: 20 ml of room temperature 5.25% sodium hypochlorite irrigation for 5 minutes and final rinse with room temperature normal saline.

Group 2: 20 ml of cryotreated (2-40 C) 5.25% sodium hypochlorite irrigation for 5 minutes and final rinse with room temperature normal saline.

Group 3: 20 ml of cryotreated (2-40 C) 5.25% sodium hypochlorite irrigation for 5 minutes and final rinse with cryotreated (2-40 C) normal saline.

After the irrigation procedure, all the canals will be dried using paper points and obturated followed by composite restoration of the access cavity. Post operative pain will be assessed by patients at the time intervals of 6 hrs, 12 hrs, 24 hrs, 48 hrs, 4 days and 7 days with the help of 10 cm Heftparker visual analogue scale (VAS). All the patients will be instructed not to take any prophylactic analagesics as, it might affect the outcome of the study and the results will be collected after one week and statistically analysed to carryout inter group comparison.

CLINICAL IMPLICATION :

Post operative pain is very common, affecting almost 60% of the subjects who have undergone endodontic treatment. Given that post-operative endodontic pain has a multi-factorial etiology, and being influenced by a variety of factors related to the subject and the tooth being treated, several strategies have been proposed to control post-operative endodontic pain. One such method is intracanal cryotherapy, in which the cryotreated irrigant solution is used to irrigate the prepared root canals to reduce the temperature of surrounding tissues. Most of the studies have shown that, reducing the root surface temperature will decrease the inflammation in periapical area leading to reduction of post operative pain. Since it is a simple and technique insensitive procedure, it can be used in routine clinical practice effectively to control the occurrence of post operative pain.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients in the age group of 20 –40 years who require endodontic therapy in mandibular premolars and have signed the informed consent.
  • 2.Mandibular premolars diagnosed with vital symptomatic irreversible pulpitis with normal periapical tissues / symptomatic apical periodontitis.
  • 3.Healthy patients without systemic disease.

排除标准

  • 1.Medically compromised patients.
  • 2.Pregnant patients.
  • 3.Teeth with incomplete apex formation.
  • 4.Teeth with calcified canals.
  • 5.Patients with swelling, sinus formation.
  • 6.Periodontally weakened tooth.
  • 7.Periapical abscess and periapical radiolucency.
  • 9.Teeth with history of trauma (i.e, TFO, Fractured cusps, etc).
  • 10.Patients on analgesics.

结局指标

主要结局

Reduction of post operative pain using cryotreated irrigant after single visit root canal treatment

时间窗: 6 hours after root canal treatment | 12 hours after root canal treatment | 24 hours after root canal treatment | 48 hours after root canal treatment | 4 days after root canal treatment | 7 days after root canal treatment

次要结局

  • Improved efficacy due to increased duration of intracanal sodium hypochlorite

研究者

发起方
Dr Naveen prasath
申办方类型
Other [Self sponsered ]
责任方
Principal Investigator
主要研究者

Naveen prasath D

Government Dental College and Hospital, Patiala, Punjab

研究点 (1)

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