Comparative Evaluation of Post-Operative Pain using Continuous and Reciprocating Motion Rotary File Systems - A Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare and evaluate continuous and reciprocating motion rotary file systems for the incidence of post operative pain.
研究概览
简要总结
This study is being done to comparatively evaluate post operative pain using ProTaper Next and TruNatomy rotary files in continuous motion and One RECI and Neo-endo reciprocation files in reciprocating motion. This clinical study will be conducted in the Department of Conservative Dentistry and Endodontics, I.T.S. Dental College, Hospital and Research Centre, Greater Noida (U.P). A total number of 100 patients reporting to the O.P.D. of Department of Conservative Dentistry and Endodontics will be selected according to the inclusion and exclusion criteria. Included patients will be informed about the study and explained in detail about the procedure of the study and requirement for the same. 100 patients will be randomly allocated into 5 groups of 20 patients each :- Group 1(n=20): Control group (Hand ProTaper), Group 2(n=20): ProTaper Next rotary file, Group 3(n=20): TruNatomy rotary file, Group 4(n= 20): One RECI reciprocating rotary file, Group 5(n=20): Neo-endo reciprocation file. No intracanal medicament will be placed in all the patients. Post operative pain will be recorded after biomechanical preparation at baseline 8 hours, 24hours, 48 hours and 72 hours telephonically using NRS scale. Thereafter, the patients will be recalled for oburation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Vital teeth indicated for intentional RCT.
- •Age group- 20-50 years.
- •Single or multi rooted teeth (radiographically and clinically assessed).
- •Patients with completely formed roots(mature apex).
- •Teeth with only Vertucci Type 1 root canal morphology.
- •Medically fit patients (i.e no general disease or pregnancy).
排除标准
- •Teeth with wide or open apex
- •Non vital teeth.
- •Endodontic retreatment cases.
- •Third molars
- •Patients using analgesics, NSAIDs oranxiolytics during 7 days before the procedure.
- •Teeth with poor prognosis.
- •Teeth with complex root canal morphology.
- •Patients unwilling to participate in the study
- •Patients with active pain in any tooth.
- •Pregnant patients and nursing mothers.
- •Presence of systemic diseases such as cardiovascular disease, renal disease and any bleeding disorders.
- •Patients with sinus tract, periapical abscess or facial cellulitis, known allergies or any contraindication to opioid or non-opioid analgesics including aspirin or NSAIDs.
- •Patients with known allergy to local anesthesia, sodium hypochlorite and chlorhexidine.
- •Presence of systemic diseases such as cardiovascular disease,diabetes mellitus, renal disease and any bleeding disorders.
结局指标
主要结局
To compare and evaluate continuous and reciprocating motion rotary file systems for the incidence of post operative pain.
时间窗: Patients will be asked to record the pain at 8 hrs, 24 hrs, 48 hrs and 72 hrs using NRS Scale.
次要结局
- To identify a rotary fie system that minimizes the incidence of post operative pain.(Pain will be recorded at 8 hrs, 24 hrs, 48 hrs and 72 hrs using NRS Scale.)
研究者
Dr Sonal Mukhraiya
ITS Dental College Hospital and Research Centre