Evaluation of post-obturation pain after using different obturation techniques in patients undergoing root canal treatment- 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
- 63
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
This study will adopt a prospective, single centered, randomized controlled clinical trial method to meet the objectives. Participants included will be between the age group of 18 to 60, who requires endodontic therapy for molars and premolars that were diagnosed as symptomatic/asymptomatic irreversible pulpitis with apical periodontitis. Participants who were medically compromised, pregnant woman, antibiotic therapy, teeth with incomplete apex formation, calcified canals, periapical abscess, and sinus opening will be excluded for the study.
The study participants will be recruited from the pool of patients in the Department of Conservative Dentistry and Endodontics at Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, India. The sample size estimation was calculated using a priori by G-power (3.0.10). The minimum sample size of each group was calculated, following these input conditions. The total sample size obtained was 57 samples with 19 samples per group. In order to compensate the drop out, sample size was kept at 63 (21 samples per group).
Block randomizationwill be done well in advance by a third person who was not related to the study using block of 9, of which number 2, 4, 5 assigned to Group I –Cold Lateral Compaction, number 1, 3, 7 to Group II – Modifed heat technique, and number 6, 8, 9 to Group III –Continuous Wave Compaction. SNOSE (sequentially numbered, opaque, sealed envelopes) method will be implemented for allocation concealment which conceals the sequence until interventions were assigned. A piece of paper containing randomized group number will be sealed in the dark coloured envelope containing respective serial number over it prepared by a third person. The group is mentioned clearly and sealed in the envelope. Patients will be assigned their study numbers as they sequentially entered the study. The envelope was opened once the intervention was assigned. Based on the group assigned in the paper, respective treatment was carried out.
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants included were between the age group of 18 to 60, who requires endodontic therapy for molars and premolars that were diagnosed as symptomatic irreversible pulpitis.
排除标准
- •Participants who were medically compromised, pregnant woman, antibiotic therapy, teeth with incomplete apex formation, calcified canals, periapical abscess, and sinus opening were excluded for the study.
结局指标
主要结局
Postoperative pain
时间窗: 12 and 24 hours
次要结局
未报告次要终点
研究者
Kavalipurapu Venkata Teja
Saveetha Dental College
