Comparative Analysis of Postoperative Pain in Single-Visit Endodontic Treatment using CurowhiteTM Enhanced Sealers versus Zinc Oxide Eugenol Sealer in mandibular premolars: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Incidence and intensity of postoperative pain will be assessed at 24, 48, and 72 hours and 1 week.
研究概览
简要总结
This study aims to evaluate the effectiveness of Curowhite-enhanced root canal sealers in reducing postoperative pain in single-rooted teeth with irreversible pulpitis, compared to traditional zinc oxide eugenol sealers. In a double-blind randomized controlled trial with 128 participants, patients aged 18-65 with single-rooted mandibular premolars will undergo single-visit root canal treatment. The study will involve four groups: zinc oxide + Curowhite (1:1) + eugenol, zinc oxide + Curowhite (1:1) + antimicrobial blend, zinc oxide + antimicrobial blend, and a control group using zinc oxide + eugenol. Pain levels will be assessed using the Visual Analog Scale (VAS) at 24, 48, and 72 hours, and at 1 week post-treatment. The study will also track the use of additional pain medication and record any adverse events. Statistical analyses will compare pain scores and analgesic requirements among the groups. The findings will help determine the efficacy of Curowhite-enhanced sealers in managing postoperative pain.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 and 65 years Single rooted mandibular premolar teeth requiring single-visit endodontic treatment Teeth with or without periapical lesions Absence of alterations causing a significant increase in preparation time.
排除标准
- •â€¢ Presence of pain in more than one tooth in the same quadrant.
- •â€¢ Teeth with open apices.
- •â€¢ Presence of systemic diseases.
- •â€¢ Missing opposing teeth or cracked teeth.
- •â€¢ Pregnant patients.
结局指标
主要结局
Incidence and intensity of postoperative pain will be assessed at 24, 48, and 72 hours and 1 week.
时间窗: 24, 48, and 72 hours patient will be reviewed through phone call and after 1 week - clinical review will be done
Participants will complete a Visual Analog Scale (VAS) questionnaire for pain intensity.
时间窗: 24, 48, and 72 hours patient will be reviewed through phone call and after 1 week - clinical review will be done
Medication usage data will be collected through patient recall and medication logs.
时间窗: 24, 48, and 72 hours patient will be reviewed through phone call and after 1 week - clinical review will be done
Adverse events will be documented and reported.
时间窗: 24, 48, and 72 hours patient will be reviewed through phone call and after 1 week - clinical review will be done
次要结局
- Periapical healing using PAI score(1 week, 6 months and 1 year)
研究者
Dr Rathna Piriyanga R S
Associate Professor