A Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate Versus Resin-based Sealers in Cases With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Postoperative pain after root canal treatment assessed using a Visual Analogue Scale (VAS)
研究概览
简要总结
This is a randomized controlled trial comparing the mean and standard deviation of postobturation pain using two different sealers: a tricalcium silicate-based sealer (CeraSeal) and a resin-based sealer (Endoplus) in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
详细描述
• The study will be conducted after approval from the Institutional Ethics Review Committee of the Armed Forces Institute of Dentistry. Informed written consent will be obtained from all patients, and demographic details (name, age, gender, and contact information) will be collected. This is a randomized clinical trial, and the sample size will be divided into two groups using computer-generated randomization. Group 1 will receive Endoplus (resin-based sealer), and Group 2 will receive CeraSeal (bioceramic sealer).
All root canal procedures will be performed by the principal investigator. At the first visit, local anesthesia (2% lignocaine with 1:100,000 epinephrine) and rubber dam isolation will be used. Working length will be determined using an apex locator and confirmed with a periapical radiograph. Chemo-mechanical preparation will be performed using 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA). Cleaning and shaping will be done up to F2 ProTaper using hand files and nickel-titanium (NiTi) rotary files, with recapitulation between each file to maintain canal patency. Non-setting calcium hydroxide will be placed as an intracanal medicament, followed by a temporary restoration with Cavit. Patients will be recalled after one week for obturation and will proceed only if asymptomatic.
At the second visit, obturation will be carried out according to group allocation. Group 1 will receive Endoplus resin-based sealer using a single-cone gutta-percha technique with a heated plugger (System B). Group 2 will receive CeraSeal bioceramic sealer with matched bioceramic cones using the same System B technique. Accessory cones will be used for wide or irregular canals. A permanent composite restoration (Coltene) will be placed, and occlusion will be adjusted.
Postoperative pain will be recorded using a Visual Analogue Scale (VAS) at 24 hours, 72 hours, and 7 days. Ibuprofen will be prescribed only if the pain becomes unbearable, and patients will document the dose and frequency taken. Two independent blinded endodontists will evaluate radiographs for technical errors or sealer extrusion. The primary measure of success will be the level of postoperative pain at follow-up, comparing outcomes between Endoplus resin-based sealer and CeraSeal bioceramic sealer.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients of age group 18 to 60 years
- •Healthy patients with ASA class 1 and 2
- •Patients of both genders
- •Teeth diagnosed as symptomatic irreversible pulpitis
- •Single as well as multirooted teeth
排除标准
- •Teeth with calcified or previously treated canals
- •Immunocompromised or mentally handicapped patients
- •Pregnant or lactating mothers
- •Teeth with periodontal probing depths of 5 mm or more
- •Cracked or un restorable teeth
- •Teeth where root canal instrumentation could not reach within 2 mm of the radiographic apex
研究组 & 干预措施
Tricalcium silicate based sealer (Bio ceramic)
CeraSeal bioceramic sealer will be used for obturation with matched bioceramic cones and a heated plugger (System B).
干预措施: Tricalcium silicate sealar (Drug)
Resin based sealer
Endoplus resin-based sealer will be used for obturation with single-cone gutta-percha and a heated plugger (System B)
干预措施: Resin based sealer (Drug)
结局指标
主要结局
Postoperative pain after root canal treatment assessed using a Visual Analogue Scale (VAS)
时间窗: 24 hours, 72 hours and 7 days
Postoperative pain will be recorded using a 10-centimeter Visual Analogue Scale (VAS). On this scale, 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores correspond to greater pain intensity, meaning more pain. Patients will self-report their pain level at each time point (24 hours, 72 hours, and 7 days). This measure will be used to compare postoperative pain between patients treated with Endoplus resin-based sealer and CeraSeal bioceramic sealer.
次要结局
未报告次要终点
研究者
Pooja Kumari
Dr. Pooja Kumari, Principal Investigator and Resident, Operative Dentistry and Endodontics
Armed Forces Institute of Dentistry, Pakistan