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临床试验/CTRI/2023/07/054831
CTRI/2023/07/054831尚未招募不适用

Comparative Evaluation of Post-operative Pain Following Single Visit Endodontics by using Two NiTi File Systems based on Different kinematics: A Randomized Clinical Study.

MGM Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
compare the of post-operative pain in

研究概览

简要总结

Title: Comparative evaluation of post-operative pain following single visit endodontics using of two NiTi file systems based on different kinematics: A Randomized clinical study.

Dental pain is most commonly induced by caries disease which is caused by specific types of bacteria. The caries disease elicits subsequent inflammation which might necessitate endodontic treatment the primary goal of endodontic treatment is to eliminate disease and manage the symptoms of the patient. Postoperative pain is an unpleasant sensory experience in patients undergoing endodontic treatment and has been reported in 25-40% of all endodontic patients. This pain is caused by the release of inflammatory mediators in the periradicular region due to increased vascular permeability and consequent oedema, which lead to the compression of nerve fibers in that region.

Extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment**.** Clinically, a

relationship exists between the presence of inflammatory mediators and the extrusion of debris, which depends on the preparation of the root

canal system.

Several clinical trials have compared the effect of reciprocating and rotation kinematics on postoperative pain and reported conflicting results, which might be attributed to the use of different instrumentation systems with different mechanical properties and designs**.** Therefore, further clinical data are necessary to elucidate the effect of endodontic instruments on postoperative pain.

This study is a prospective, single-centre, double blind randomized clinical study with a concurrent parallel study design. Consecutive, Consenting sampling. Comparison will be done on of postoperative pain following single visit endodontics after the use of two NiTi file systems based on different kinematics: 80 patients will be selected on the basis of inclusion and exclusion criteria. Which further divide into 40 participants each. The patient will be allotted to one of the instrumentation techniques by random allocation using Graph pad by domatics software. Concealment allocation will be carried out by using sequentially numbered sealed opaque envelopes by a neutral observer. After randomization, allotted group will be written on a paper and kept in an opaque sealed envelope

Group 1: Root canals will be prepared by TruNatomy rotary system.

Group 2: Root canals will be prepared by WaveOne Gold reciprocating system. Cleaning and shaping of the canal will ne by done in which.

The patient will be given post-operative instructions and will be recalled at the following intervals: 6 hours, 24 hours and 7 days, and evaluated

for pain scale. Pain assessment will be done with the help of visual analogue scale (VAS). Participants will be asked to place a single mark on line to indicate current level of the pain. Using a ruler, distance was measured in mm from “no pain†anchor to mark on visual analogue scale line.

Although all instrumentation techniques produce apical extrusion of debris, the difference lies in the ability of some techniques to extrude less debris than others.

The rationale of this study is to evaluate the of post-operative pain in patients with chronic irreversible pulpitis following single-visit endodontics using two different nickel-titanium file systems based on different kinematics. This study would determine whether the use of the instruments would influence the occurrence of post-operative pain

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.All vital single-rooted teeth with irreversible pulpitis, whether associated with or without apical periodontitis, and mild to moderate pain (VAS value 5-74mm) indicated root canal treatment.2.Maxillary and mandibular premolars with single root and single canal.3.Patients with single rooted permanent teeth with periapical radiolucency less than 1.5 mm as determined by an intraoral periapical (IOPA) radiograph.
  • 4.Teeth with fully developed apex and straight canals with minimal curvature (0 to 10 degrees) 5.Teeth with healthy periodontium with periodontal probing depth 3.

排除标准

  • 1.Pregnant women and lactating mothers.
  • Patients with acute dentoalveolar abscess or cellulitis.
  • Patients presenting with severe pain (75-100mm).
  • Patients who have taken antibiotics and analgesics and corticosteroid in the past month.
  • 5.Patients with known immunocompromised conditions (e.g., AIDS) 6.Patients who are known diabetic.
  • 7.Patients with non-vital teeth and intraoral and extraoral sinus tract 8.Patients with radiographic evidence of radiolucency of more than 1.5 mm
  • open apex, root resorption.
  • presence of root caries and multirooted teeth
  • Teeth with aggressive periodontitis and grade III mobility, periodontal probing depth >3mm.

结局指标

主要结局

compare the of post-operative pain in

时间窗: The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.

two different rotary instrument systems. For each patient, the

时间窗: The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.

single-visit endodontics where canal instrumentation will be done using

时间窗: The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.

preoperative and post-operative pain levels will be recorded by using a

时间窗: The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.

visual analogue scale (VAS)

时间窗: The assessment of the post-operative pain will be conducted at intervals of 6 hours, 24 hours, and 7 days after the initial visit.

次要结局

未报告次要终点

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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