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临床试验/CTRI/2021/11/038013
CTRI/2021/11/038013尚未招募2 期

Evaluation Of Post-Operative Quality Of Life In Patients Undergoing Two Visit Root Canal Therapy Following Final Irrigation With Cold Saline Or Diclofenac Sodium Solution -A Prospective Randomized Controlled Trial

Pavithra S Sidharth Sivakumar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月22日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Post-Operative Quality of Life(Difficulty in chewing, speaking, sleeping, carrying out daily functions, social relations and overall QoL) and post-operative pain will be evaluated after 24,48,72 hours and 7 days

研究概览

简要总结

The aim of this study is to evaluate the Post-operative Quality of Life in patients undergoing root canal therapy in two-visits following final irrigation with cold saline(2.5°C) or

Diclofenac Sodium solution

Outcomes •To evaluate Post-Operative Quality of life using questionnaires

•To evaluate post-operative pain using visual analogue scale scoring at 24,48,72 hours and 7days

•60 patients reporting with pain divided into two groups by randomization.

•Group I (n=30) - final irrigation with cold saline (2.5°C) and group II(n=30) – final irrigation with diclofenac sodium solution, respectively.

STUDY POPULATION: Individuals reporting with pain in teeth and attending the Department of Conservative dentistry and Endodontics of Sri Ramakrishna Dental College

and Hospital, Coimbatore will be included in this study.

STUDY DESIGN:PROSPECTIVE interventional study

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
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

  • Teeth diagnosed with symptomatic or asymptomatic irreversible pulpitis with or without apical periodontitis (acute or chronic) Primary root canal treatment in fully matured mandibular molars Teeth with enough crown structure for adequate isolation.

排除标准

  • Presence of periapical and periodontal lesions Teeth with complex root anatomy, resorption, re-treatment and calcifications Patients with chronic systemic disease and pregnant patients Patients who received analgesics or antibiotics within the preceding 6 hours before the procedure.

结局指标

主要结局

Post-Operative Quality of Life(Difficulty in chewing, speaking, sleeping, carrying out daily functions, social relations and overall QoL) and post-operative pain will be evaluated after 24,48,72 hours and 7 days

时间窗: 24,48,72, hours and 7 days

次要结局

  • Postoperative pain (mean and maximum pain) will be assessed through a visual analogue scale (VAS)(24,48,72, hours and 7 days)

研究者

发起方
Pavithra S Sidharth Sivakumar
申办方类型
Other [self]

研究点 (1)

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