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临床试验/CTRI/2021/03/031957
CTRI/2021/03/031957已完成不适用

COMPARATIVE EVALUATION OF POST-OPERATIVE PAIN FOLLOWING CHEMO-MECHANICAL PREPARATION OF SINGLE ROOTED NON-VITAL TEETH WITH SYMPTOMATIC APICAL PERIODONTITIS WITH AND WITHOUT LASER IRRADIATION: A SINGLE BLIND RANDOMIZED PLACEBO CONTROLLED CLINICAL TRIAL

Dr Shreya Shivangi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Post operative pain scores

研究概览

简要总结

Pain management is one of the most important aspects of endodontic treatment. Infected root canals are the most common cause of endodontic pain. Pain may also be induced following conventional endodontic therapy and even with recently available techniques total eradication of the bacteria is almost unachievable. In the recent years, use of diode lasers has gained acceptance in the endodontic field. It was found by Pawar et al. and Bjordal et al. that the diode laser acted on pain and had an anti-inflammatory effect by decreasing PGE2, bradykinin, acetylcholine, histamine, serotonin, and substance P. In earlier studies related to lasers, the use of lasers was limited to treating dentinal hypersensitivity, for its effects on vital pulpotomy, and for evaluating postoperative pain and swelling in patient undergoing extractions of impacted 3rd molar. Lately, studies performed for evaluating post-operative endodontic pain using lasers showed varying results of significant differences between control groups and test group as well as comparable differences between the two. Therefore, it remains debatable whether laser therapy is effective in reducing post-operative pain after endodontic treatment or not. According to our literature search, we found only a few studies evaluating the use of lasers for post-operative endodontic pain reduction which were mostly for the International populations. Also, to the best of our knowledge, Biolase EpicX and Pro HS Niti Rotary systems have not been used in the investigations for the same. Therefore, this clinical study proposes to investigate the incidence of post-operative pain following chemo-mechanical preparation of single rooted teeth (using Pro HS Niti Rotary systems) having symptomatic apical periodontitis with and without laser irradiation (by Biolase EpicX) for the Indian population.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects older than 18 years of either gender.
  • Subjects having a single rooted non-vital tooth with symptomatic apical periodontitis needing primary endodontic treatment.
  • Cooperative health subjects who are willing to participate in the study and sign the consent form.

排除标准

  • Subjects with uncontrolled systemic diseases or allergies.
  • History of previous root canal treatment.
  • Presence of swelling or sinus tracts.
  • Presence of severe periodontal disease.
  • Periapical radiolucency.
  • Subjects who’ve taken analgesics within the last 3 days.
  • Subjects allergic to local anesthesia.
  • Subjects unwilling to sign the consent form.

结局指标

主要结局

Post operative pain scores

时间窗: Post operative pain scores at 24 hours, 48 hours, and 72 hours

次要结局

  • Percussion pain scores(Pre-operative percussion pain score and post - operative percussion pain score (at 72 hours))

研究者

发起方
Dr Shreya Shivangi
申办方类型
Other [self]

研究点 (1)

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