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临床试验/CTRI/2024/07/071647
CTRI/2024/07/071647招募中4 期

Effect of Ascorbic acid on occurrence and severity of post endodontic pain following root canal treatment on teeth with irreversible pulpitis. A triple-blind randomized placebo-controlled trial

Dr Shahnaz1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Success of preoperative ascorbic acid in reducing post-endodontic pain post-operatively after endodontic treatment.

研究概览

简要总结

Complete pain alleviation is a necessary precondition for endodontic therapy to be successful. Although microorganisms are commonly thought to be the primary cause of postoperative pain, pulpal or peri-radicular tissues may also be injured mechanically or chemically. Prostaglandins, leukotrienes, bradykinin, and serotonin are inflammatory mediators that activate sensitive nociceptors and cause postoperative endodontic pain. This can result in both peripheral and central mechanisms of hyperalgesia. Non-steroid anti-inflammatory medicines (NSAIDs), which are often used postoperative analgesics, have been linked to undesirable side effects, such as respiratory suppression, as well as other relatively mild issues, including nausea or vomiting. The L-enantiomer of ascorbate, or ascorbic acid, is commonly referred to as vitamin C and is a water-soluble antioxidant that may be found in a wide range of fruits and vegetables. There aren’t many research currently available assessing ascorbic acid’s impact on post endodontic pain. Therefore, the goal of this study is to clarify how well ascorbic acid works in situations with irreversible pulpitis to reduce immediate postoperative pain after root canal therapy.

Aim: evaluate the effect of ascorbic acid preoperatively on post endodontic pain reduction following endodontic treatment in irreversible pulpitis cases.

Objectives:

1)      Evaluate the effect of ascorbic acid on reduction of post endodontic pain at 4hrs, 8 hrs. 12 hrs, 24 hrs., and 48 hrs. Postoperatively in cases with preoperative irreversible pulpitis.

2)      Compare the effect of ascorbic acid with placebo in reduction of post endodontic pain.

Material and methods: This study will be a prospective parallel arm randomized triple -blind placebo-controlled trial. The study will be carried out in the Department Of Conservative Dentistry And Endodontics, Faculty of Dentistry, and Jamia Millia Islamia.60 patients (30 per group) with symptomatic irreversible pulpitis will be recruited for the study. The patients will be divided into two Groups. Group 1 will be given 500 mg ascorbic acid, one hour before the local anaesthesia. Group 2 patients will be given placebo multivitamin tablet one hour before local anaesthesia... Each patient willrecord their pain score on a heft parker visual analog scale before taking the medicine, at 4hrs, 8 hrs, 12 hrs, 24 hrs, and 48 hrs postoperatively.

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, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Healthy patients having a tooth with symptomatic irreversible pulpitis and normal periapical radiographic appearance.

排除标准

  • Presence of systemic disorders, a sensitivity to lidocaine with 1:80,000 epinephrine or a history of gastrointestinal ulcers, lactation, pregnancy, using any type of analgesic medication in the preceding 12 hours before the treatment, having a tooth not suitable for restoration, and having a full crown.

结局指标

主要结局

Success of preoperative ascorbic acid in reducing post-endodontic pain post-operatively after endodontic treatment.

时间窗: 4hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs postoperatively

次要结局

  • Compare the effects of ascorbic acid & placebo on post-endodontic pain reduction after endodontic treatment.(4 hrs 8 hrs 12 hrs 24 hrs & 48 hrs)

研究者

发起方
Dr Shahnaz
申办方类型
Other [PRIMARY INVESTIGATOR]
责任方
Principal Investigator
主要研究者

Dr Shahnaz

Faculty Of Dentistry, Jamia Millia Islamia

研究点 (1)

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