Evaluation of the Effect of Resin-Based and Bioceramic Sealers on Postoperative Pain in Mandibular Molars With Asymptomatic Apical Periodontitis Treated in a Single Visit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Postoperative Pain Level
研究概览
简要总结
This study aims to evaluate the effect of two different root canal sealers-BioRoot RCS (a bioceramic-based sealer) and AH Plus (a resin-based sealer)-on postoperative pain following single-visit root canal treatment in mandibular first and second molars diagnosed with asymptomatic apical periodontitis. Postoperative pain levels will be assessed at multiple time intervals to determine whether the type of canal sealer influences patient discomfort after treatment.
详细描述
Asymptomatic apical periodontitis is a common condition requiring root canal treatment, and postoperative pain is an important outcome that affects patient comfort and clinical decision-making. Root canal sealers play a critical role in the success of endodontic therapy, and their physical and biological properties may influence postoperative symptoms.
This study compares a bioceramic-based sealer (BioRoot RCS) and a resin-based sealer (AH Plus) in patients receiving single-visit root canal treatment for mandibular first and second molars with asymptomatic apical periodontitis. Participants will be randomly assigned to one of the two sealer groups. Pain intensity will be recorded using a validated pain scale at predetermined time intervals following treatment. The findings of this study may help clinicians select sealers based on their impact on postoperative pain and improve patient outcomes.
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 (Participant)
盲法说明
his study uses a single-blind masking design. Participants are blinded to the type of root canal sealer used during treatment, but the care provider performing the procedure is not blinded. Postoperative pain is self-reported by participants using a standardized pain scale.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older with adequate oral hygiene.
- •Teeth with no previous endodontic or restorative treatment.
- •Teeth that do not respond to cold test and electric pulp test during vitality assessment.
- •Teeth that are asymptomatic prior to treatment.
- •Mandibular first or second molar teeth with complete root development.
- •No bleeding observed in the pulp chamber after caries removal.
- •Teeth with a Periapical Index (PAI) score of 3 or less.
- •Patients who have not used antibiotics within the last 1 month.
- •Patients who have not used analgesics within the last 72 hours.
排除标准
- •Presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, immunosuppression).
- •Pregnancy or breastfeeding.
- •Teeth with a history of trauma, resorption, or previous endodontic access.
- •Teeth with root canal calcifications or anatomical abnormalities preventing standard instrumentation.
- •Presence of sinus tract, swelling, or acute apical abscess.
- •Teeth with a Periapical Index (PAI) score greater than
- •Patients taking medications that may alter pain perception (e.g., corticosteroids, neuropathic pain medications).
- •Patients unable to comply with follow-up pain recordings.
- •Patients with known allergy to any materials used in the study (e.g., sodium hypochlorite, sealers).
结局指标
主要结局
Postoperative Pain Level
时间窗: First 7 days after treatment (24 hours, 48 hours, 72 hours, and 7 days)
Postoperative pain will be recorded using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will report their pain levels at 24 hours post-treatment, 48 hours post-treatment, 72 hours post-treatment, and on 7 days post-treatment following single-visit root canal treatment.
次要结局
未报告次要终点
研究者
AZİZ ŞAHİN ERDOĞAN
Assistant Professor of Endodontics
Ataturk University