Comparison of the Clinical Effectiveness of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer in Single-visit Root Canal Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in treatment outcome evaluation over time
研究概览
简要总结
Background: Sealers have been concerned with obturation. However, studies for assessing the effectiveness of endodontic treatment of sealer based on Calcium Silicate have been not much.
Objective: This study aimed to assess the effectiveness of endodontic treatment of sealer based on Calcium Silicate Methods: A prospective, single-blind, clinical trial was conducted from June 2020 to December 2020 with 42 irreversible pulpitis teeth by one clinician. The postoperative pain was assessed after root canal treatment using sealer based on Calcium Silicate and sealer based on Epoxy resin after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days and inconvenient symptoms were assessed after 7 days, 3 months and 6 months. t-test, Mann-Whitney and Wilcoxon analysis were applied.
Key words: obturation, sealer based on Calcium Silicate and sealer based on Epoxy resin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18 years or older
- •teeth diagnosed with irreversible pulpitis by electrical and thermal tests (+)
- •had clinical symptoms like continuous or spontaneous pain, teeth exposed to sudden temperature changes, especially cold stimuli, causing sharp pain and persisting after stimulus removal
- •these teeth must have healthy periodontal tissue and sufficient clinical teeth crown for isolation with a rubber dam
- •Exclusion criteria:
- •Patients with:
- •Have a systemic disease requiring antibiotics or have an allergic reaction
- •Have maxillofacial pathology, cellulitis, occlusal trauma, and temporomandibular disorders, have endodontic periodontal lesions, periodontal abscesses
- •Have taken a previous pain reliever within 24 hours
- •Roots internally or externally resorbed, cracked or broken
- •Have had failed endodontic treatment, or the root canal cannot be controlled for leakage
- •No opposing teeth
排除标准
- 未提供
研究组 & 干预措施
Epoxy resin-based sealers (ERS)
After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS)
干预措施: Calcium silicate-based sealers (CSS) (Drug)
calcium silicate-based sealers (CSS)
After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS)
干预措施: Epoxy resin-based sealers (ERS) (Drug)
结局指标
主要结局
Change in treatment outcome evaluation over time
时间窗: 1 week, 3 months and 6 months after treatment
Based on Strindberg's criteria of clinical symptoms, the treatment outcome evaluation was then expressed as success, failure, or uncertain depending on the presence of symptoms
Change in pain intensity over time
时间窗: after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
The investigator instructed patients on how to use the 170-mm Heft-Parker self-assessment scale to evaluate their pain intensity. Swelling, fistula, and sensitivity under biting pressure were classified as binary variables.
Change in pain relief over time
时间窗: after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
The investigator instructed patients on how to use the 170-mm Heft-Parker self-assessment scale to evaluate their pain intensity. Swelling, fistula, and sensitivity under biting pressure were classified as binary variables.
次要结局
未报告次要终点
研究者
Tran Ngoc Minh Duyen
University Post Graduated Student
University of Medicine and Pharmacy at Ho Chi Minh City