Evaluation of Post -Operative Pain After Obturation Using Two Different Types of Sealers - A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- post operative pain in both sealer groups after obturation
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate pain after root canal treatment using two different kinds of sealers during obturation in 60 healthy , male and female patients ages between 18 to 40 years. The main aims is to systematically evaluate and compare post-operative pain levels in patients undergoing root canal treatment with two different types of endodontic sealers: AH plus (SEAL APEX) and bio ceramic sealer(META)
• By identifying the sealer that leads to the least discomfort, this research could significantly enhance patient care, minimize recovery time, and improve overall treatment success in endodontics.
Participants in both groups will be given a visual analogue scale(VAS) to measure the pain level after the root canal treatment has been completed. They will measure pain levels at 12, 24 and 48 hours. All information will be recorded on proforma and compared.
详细描述
•This randomized clinical trial is done to evaluate and compare post operative pain after obturation using two different sealers .A total of 60 participants will be selected using a non-probability consecutive sampling method. After enrollment, participants will be randomly allocated into two equal groups (30 each),Group A and Group B using the lottery method. Group A patients will be given AH plus sealer and Group B will be given bio-ceramic sealer. Root canal treatment will be performed in two visits using local anesthesia under rubber dam isolation. • After drying with paper points , in group 1 an even ratio of 1:1 from the base and catalyst of the AH plus will be manually mixed on a paper pad with a spatula and introduced into the canal on the master cone.
- In group B, sealer will be introduced with the bio ceramic sealer tube and cold lateral compaction technique will be used for obturation in both of the groups . Composite will be used for restoration.
- The patients will be called again for evaluation of pain and its severity at, 24hrs, 48hrs and 72hrs. Effectiveness of sealers will be measured as no, mild, moderate or severe pain on visual analogue scale (VAS). All procedures will be done under the supervision of supervisor. All this information will be recorded on proforma.
- Patients shall be prescribed ibuprofen 400mg post-operatively shall be prescribed. Patients will be given VAS scale so they can record their pain at home before taking the analgesic.
- Data will be entered and analyzed in IMB SPSS version 26. Mean and Standard deviation (SD) of VAS scores at each time point (12h, 24h, 48h) for both types of sealers shall be calculated. Independent t-test to compare the VAS scores between two groups (Sealer 1 vs. Sealer 2).
- Significance level to set at p value <0.05 this study will further add to the literature regarding the efficacy of sealer in reducing post operative pain and assessing which sealer is better and effective to use for clinicians.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients ranging from 18 to 40 years.
- •Patients whose teeth have been diagnosed with Symptomatic irreversible pulpitis.
- •maxillary and mandibular teeth.
- •A normal periapical condition on radiograph, or one with little to no periodontal ligament (PDL) space widening, confirming the normal periapical state.
- •Teeth that can be restored.
- •Teeth with healthy periodontium.
排除标准
- •Non-restorable teeth.
- •Patients with poor health whose systemic complications could change the course of treatment.
- •Teeth with immature roots.
- •Teeth with periapical lesions or apical periodontitis.
- •Teeth with Necrotic pulp.
研究组 & 干预措施
Group A , AH plus sealer , Group B ( bioceramic sealer)
patients in group A will recieve AH plus sealer and in group B shall recieve bioceramic sealer for obturation during root canal treatment
干预措施: bioceramic sealer (Drug)
Group A , (AH plus sealer ) , Group B ( bioceramic sealer)
patients in Group A will recieve Ah plus sealer for obturation and patients in group B shall recieve bioceramic sealer for obtration during root canal treatment second visit
干预措施: AH-Plus Epoxy Resin Sealer (Drug)
结局指标
主要结局
post operative pain in both sealer groups after obturation
时间窗: 6 months
Post-operative pain levels will be measured and compared in both groups using Visual Analogue Scale (VAS) Patients were asked to rate their pain on a numerical scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst pain imaginable. For interpretation, pain intensity was categorized as follows: 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
次要结局
未报告次要终点
研究者
Jaweria Gul Keyani
Post Graduate Trainee
Margalla Institute of Health Sciences