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临床试验/CTRI/2023/04/051599
CTRI/2023/04/051599招募中4 期

A Comparative Evaluation of Postoperative Pain in Patients undergoing Root Canal Treatment with Four Different Types of Sealers: A Randomized Controlled Trial

All India Institute of Medical Sciences, Jodhpur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月6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
100
试验地点
1
主要终点
To comparatively evaluate the incidence of post-operative pain using four different classes of sealers (Tubliseal, AH Plus, BioRoot RCS and Nishika Canal Sealer BG) following root canal therapy.

研究概览

简要总结

Postoperative pain is an unwanted yet unfortunately a common sensation after endodontic treatment. The incidence of postoperative pain has been reported to range from 3% to 58%. There is no single factor affecting pain after root canal treatment and it may be due to mechanical, chemical and/or microbial injury to the pulp or peri-radicular tissues, further irrigating solutions, medications and sealers can evoke pain by irritating the periradicular tissues. Any intracanal sealer that has a reduced the risk of extrusion into periapical tissues would help the patient and the clinician because such a root canal sealer could decrease postoperative discomfort. Thus, the present clinical trial aims to comparatively evaluate four different root canal sealers (Tubliseal, AH Plus, BioRoot RCS and Nishika Canal Sealer BG) on causing post operative pain in patients with symptomatic irreversible pulpitis or apical periodontitis following root canal therapy. A total of 100 patients who meet the inclusion criteria will be enrolled for the clinical trial and four different sealers will be used belonging to four different compositions. These will be manipulated as per the manufacturer’s instructions, carried into the root canal coated on a gutta percha point and applied onto the root canal walls in an anticlockwise motion. This application shall be repeated three times.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients between the age group of 18 years to 65 years
  • Single rooted teeth with single apical exit.
  • Patients with no signs of immature apex or previously initiated RCT.
  • Patients with symptomatic irreversible pulpitis or apical periodontitis.

排除标准

  • Patients who had taken analgesic or anti-inflammatory drugs within the last 12 hours of root canal obturation.
  • Pregnancy or lactation
  • Teeth with calcified canals
  • Teeth with periodontal diseases
  • Teeth with root resorption
  • Teeth with immature/open apex
  • Previously treated or initiated tooth.

结局指标

主要结局

To comparatively evaluate the incidence of post-operative pain using four different classes of sealers (Tubliseal, AH Plus, BioRoot RCS and Nishika Canal Sealer BG) following root canal therapy.

时间窗: Post-operatively 24 hrs, 72 hrs, 7 days

次要结局

  • To comparatively evaluate the ability of four different classes of sealers for greater flow and to corelate incidence of apical extrusion of sealer with postoperative pain following root canal therapy.(Post-operatively 24 hrs, 72 hrs, 7 days)
  • To comparatively evaluate the radio-opacity of the obturated root canal with four different classes of sealers.(Post-operatively)

研究者

发起方
All India Institute of Medical Sciences, Jodhpur
申办方类型
Government medical college

研究点 (1)

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