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临床试验/CTRI/2024/09/074529
CTRI/2024/09/074529尚未招募不适用

Comparative Evaluation of Ceraseal, MTA Fillapex and AH Plus sealer on postoperative pain after single visit root canal treatment - A Randomized controlled Clinical trial

Monal Ajay Kohok1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月1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
90
试验地点
1
主要终点
To compare the incidence and intensity of postoperative

研究概览

简要总结

Single-visit root canal treatment offers numerous benefits that significantly enhance patient experience and clinical outcomes. One of the most compelling advantages is the substantial reduction in treatment time, allowing patients to complete their procedure in one appointment and minimizing disruption to their daily lives. Additionally, this approach can alleviate dental anxiety, as it reduces the stress associated with multiple appointments, including the need for repeated anaesthetic injections and rubber dam placements. Importantly, single-visit treatment significantly lowers the risk of root canal contamination and bacterial regrowth, which can occur with prolonged treatment intervals. By maintaining continuity, clinicians can better understand canal anatomy, tooth length, and other vital parameters, enhancing treatment precision while avoiding complications such as inter-visit leakage and loss of temporary seals. However, it is essential to acknowledge certain limitations of single-visit procedures. The absence of diagnostic controls available in multi-visit treatments may hinder the ability to culture samples for assessing the effectiveness of biomechanical preparation or to evaluate tissue responses post-treatment. Moreover, in the event of a flare-up or complications, emergency interventions can become more complex, requiring procedures such as artificial fistulation or the removal of fillings. Ultimately, while single-visit root canal treatment provides significant advantages, both patients and clinicians must weigh these benefits against potential limitations to ensure informed decision-making for optimal dental health outcomes.

This randomized controlled trial aims to assess postoperative pain following single-visit root canal treatment in mandibular first molars, comparing the efficacy of three endodontic sealers: Ceraseal, MTA Fillapex, and AH Plus. Recognizing that pain perception is a complex and subjective experience influenced by numerous physical and psychological factors, this study will employ the Visual Analog Scale (VAS) for pain measurement. The VAS, a 100 mm horizontal line anchored by descriptive terms at each end, will be used to quantify patients’ pain levels. Participants will be instructed to mark their perceived pain at specified intervals: 6 hours, 12 hours, 24 hours, 48 hours, 3 days, and 7 days post-treatment. This methodology aims to provide a robust comparison of postoperative pain associated with the different sealers under investigation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
21.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Teeth necessitating endodontic treatment on asymptomatic permanent mandibular first molars, confirmed as vital through pulp sensitivity tests, will be selected for this study from the regular patient pool.
  • The treatment procedure will be thoroughly explained to each patient in their native language to ensure comprehension.
  • Informed written consent will be obtained prior to participation, adhering to ethical standards and ensuring patient autonomy.

排除标准

  • Pregnant patients, medically compromised patients (with immunosuppressive, systemic diseases, patients on medications), and patients below 21 years and above 30 years of age will be excluded.

结局指标

主要结局

To compare the incidence and intensity of postoperative

时间窗: 6, 12, 24, 48 hours and 3rd and 7th day

pain following single-visit root canal treatment using

时间窗: 6, 12, 24, 48 hours and 3rd and 7th day

Ceraseal, MTA Fillapex and AH Plus sealer among patients.

时间窗: 6, 12, 24, 48 hours and 3rd and 7th day

次要结局

  • To assess the need for analgesic medication consumption(among patients in each sealer group to manage)

研究者

发起方
Monal Ajay Kohok
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Monal Ajay Kohok

Nair Hospital Dental College

研究点 (1)

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