Per-operative and post-operative pain assessment after using XP-Endo Shaper Plus Sequence and Trunatomy rotary endodontic file for non-surgical root canal treatment: A randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Incidence of pain following root canal instrumentation using XP-Endo Shaper Plus File
研究概览
简要总结
AIM OF THE STUDY: To evaluate and compare incidence of pain during and after non-surgical endodontic treatment of teeth with symptomatic irreversible pulpitis using XP-Endo shaper plus and TruNatomy file system
MATERIALS AND METHODS:
The study is designed as a prospective, randomized, double blinded, clinical trial. 40 patients will be enrolled from the Department of Conservative Dentistry and Endodontics who are systemically healthy between 15-40 years of age and fulfilling the inclusion criteria of the study. Patient will be randomly assigned into two equal groups using Simple Random Sampling by rolling a dice. Odd number will be assigned to Group 1 (1,3,5) and even number will be assigned to Group 2 (2,4,6).
Group 1: Instrumentation using XP-Endo Shaper plus sequence
Group 2: Instrumentation using Trunatomy file sequence
Patient and outcome assessor will be blinded to the groups of the study. The randomized order of instrumentation procedure will be enclosed in sealed, opaque envelopes. Treatment will be carried out in 2 visits. In first visit, root canal treatment will be performed upto biomechanical preparation. In group 1, instrumentation will be done with XP-Endo shaper plus and in group 2, instrumentation will be done with Trunatomy file system. In the 2nd visit, obturation will be done. Each of the 40 patients, will be taught how to use VAS scale. On a scale of 1-10, the patient will be asked to rate their pain. Pain will be evaluated at following time intervals: immediately after BMP, 24 hours, 3 days, 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient without any systemic disease
- •Patient diagnosed with Symptomatic Irreversible Pulpitis in single rooted premolars
- •Teeth with canal curvature less than 30 degree
- •Teeth which are not tender on percussion
- •Teeth without any periapical lesion.
排除标准
- •Patient with uncontrolled systemic disease, co-morbidities
- •Patient with known allergies to local anaesthesia, sodium hypochlorite, analgesics
- •Pregnant and lactating patient
- •Patient with a history of medication (analgesic, antibiotic) 15 days before operation
- •Teeth with multiple roots, complex root canal anatomy, calcified canals
- •Teeth with root caries
- •Non-vital teeth
- •Case of previous endodontic treatment
- •Teeth with immature/open apex
- •Teeth with periapical radiolucent lesion, sinus tract, abscess, facial cellulitis.
结局指标
主要结局
1. Incidence of pain following root canal instrumentation using XP-Endo Shaper Plus File
时间窗: Pain will be assessed at following time intervals- immediately after biomechanical preparation, 24 hours, 3 days, 7 days
2. Incidence of pain following root canal instrumentation using TruNatomy file system
时间窗: Pain will be assessed at following time intervals- immediately after biomechanical preparation, 24 hours, 3 days, 7 days
3. Comparative evaluation of pain experienced following root canal instrumentation using XP-Endo Shaper Plus and TruNatomy file system
时间窗: Pain will be assessed at following time intervals- immediately after biomechanical preparation, 24 hours, 3 days, 7 days
次要结局
- Comparative evaluation of pain experienced following root canal instrumentation using XP-Endo Shaper Plus and TruNatomy file system(Immediately after BMP, 24 HOURS, 3 days, 7 days)