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临床试验/CTRI/2025/07/091392
CTRI/2025/07/091392尚未招募不适用

Comparison of Post-Operative Pain in Endodontically Treated Teeth with Asymptomatic Irreversible Pulpitis with Two Rotary File Systems and Two Endodontic Motors: A Randomized Controlled Trial

Dr Simran Baliga1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Post-operative pain recorded using the Visual Analogue Scale with scores ranging from 0-10

研究概览

简要总结

Root canal treatment is a commonly performed dental procedure which is performed when the pulp of the tooth is irreversibly damaged. Devices like the apex locator and endomotor are used as part of the procedure along with other instruments. The apex locator allows the dentist to locate the apex of the tooth and the endomotor allows the operator to clean and shape the root canal of the tooth.

Although these devices are available separately, recently there have been new ’integrated’ endomotors introduced which combine these devices into a single device i.e., an endomotor with an in-built apex locator. Along with these devices, rotary files are used to clean and shape the root canal of the tooth. These files may be of many sizes, cross-sectional shapes and configurations, made of different materials with other differences. The literature comparing different commercially available file systems is vast, however the literature comparing a new file system along with the use of the integrated endomotor is scarce as compared to more commonly used file systems. Pain post root canal treatment is frequently reported and may be due to several factors like extrusion of debris or irrigation solutions beyond the apex of the tooth. This study aims to compare two file systems with an endomotor and integrated endomotor on the incidence of post-operative pain.

RESEARCH QUESTION:

Is there a difference in the incidence of post-operative pain after root canal treatment in teeth with asymptomatic irreversible pulpitis between two different rotary file systems and two different endomotors?

RESEARCH HYPOTHESIS (H1):

There is a difference in the incidence of post-operative pain after root canal treatment in teeth with asymptomatic irreversible pulpitis between two different rotary file systems and two different endomotors

NULL HYPOTHESIS (H0):

There is no difference in the incidence of post-operative pain after root canal treatment in teeth with asymptomatic irreversible pulpitis between two different rotary file systems and two different endomotors

Pre-operative pain will be recorded as the baseline.

Post-operative pain in all participants will be recorded using the Visual Analogue Scale (VAS) with scores ranging from 0 to 10.

The intensity of pain perceived by the participant will be assessed at the time intervals of 24 hours, 48 hours, 72 hours, and 7 days using the Visual Analogue Scale (VAS).

The pain intensity according to the Visual Analogue Scale (VAS) will be categorized as a score of 0 indicative of no pain or score of 7-10 indicative of severe pain

Pain scores will be subjected to statistical analysis.

The follow-up of the perceived pain will be performed over the telephone by the outcome assessor not part of the study at time intervals of 24 hours, 48 hours, 72 hours, and 7 days using the Visual Analogue Scale (VAS).

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Maxillary premolars of patients aged 20 to 50 years 2) Mature apices 3) Asymptomatic 4) Diagnosis of irreversible pulpitis with or without apical periodontitis (determined using cold and electric pulp test) 5) Written informed consent prior to study procedure.

排除标准

  • Analgesic consumption within 24 hours 2) Greater than 25° root canal curvature 3) Complex root canal morphology 4) Re-treatment / Re-root canal treatment 5) Allergic reactions 6) Presence of evidence of any other periapical pathologies 7) Any systemic disease 8) Pregnancy or breastfeeding 9) Inability to understand or provide consent for procedure.

结局指标

主要结局

Post-operative pain recorded using the Visual Analogue Scale with scores ranging from 0-10

时间窗: Baseline i.e., pre-treatment pain

次要结局

  • - To check if integrated apex locator is more efficient than conventional endomotors(- To check if 2 different file systems are similar or different in shaping efficiency)

研究者

发起方
Dr Simran Baliga
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr R Anitha Kumari

Vokkaligara Sangha Dental College & Hospital

研究点 (1)

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