ASSESSMENT OF POST OPERATIVE PAIN AFTER DIFFERENT IRRIGATION ACTIVATION TECHNIQUES WITH ROTARY AND RECIPROCATING FILE SYSTEM IN SINGLE VISIT ENDODONTIC TREATMENT A CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Assessment of post-operative pain levels
研究概览
简要总结
Title of Study: Assessment of Post-Operative Pain After Different Irrigation Activation Techniques with Rotary and Reciprocating File Systems in Single-Visit Endodontic Treatment: A Clinical Study.
Study Objective: The objective of this study is to evaluate and compare the post-operative pain levels experienced by patients undergoing single-visit endodontic treatments using different irrigation activation techniques (Pro-agitator Tip System (PATS), EndoActivator, Ultra X-Cordless Endodontic Ultrasonic Device) in combination with rotary and reciprocating file systems (E-Flex Rec and NeoEndo Flex).
Study Design: This is an in vivo, randomized, stratified, parallel clinical trial. A total of 90 patients will be enrolled and randomly assigned to six treatment groups (15 patients per group). Each group will receive one combination of irrigation activation technique and file system.
Inclusion Criteria:
- Patients aged between 18 and 65 years.
- Patients with symptomatic apical periodontitis requiring single-visit endodontic treatment on single-rooted teeth.
- Patients willing to provide informed consent and available for follow-up.
Exclusion Criteria:
- Teeth with large (>5mm) periapical lesions, history of RCT, abscess, cellulitis, or complicating systemic diseases.
- Patients with allergies to any of the materials or irrigants used in the study.
Interventions:
- Group 1: PATS Vario with NeoEndo Flex File System.
- Group 2: PATS Vario with E-Flex Rec File System.
- Group 3: EndoActivator with NeoEndo Flex File System.
- Group 4: EndoActivator with E-Flex Rec File System.
- Group 5: Ultra X-Cordless Endodontic Ultrasonic Device with NeoEndo Flex File System.
- Group 6: Ultra X-Cordless Endodontic Ultrasonic Device with E-Flex Rec File System.
Primary Outcome: Post-operative pain levels assessed using the Visual Analog Scale (VAS) at 8 hours, 24 hours, and 48 hours after treatment.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged between 18 and 65 years Patients with good general health available for follow-up Single-rooted teeth with symptomatic apical periodontitis Willingness to provide written informed consent.
排除标准
- •Teeth with extremely large or incompletely formed apices Abscess or cellulitis Complicating systemic diseases.
- •History of allergic reactions to irrigants.
结局指标
主要结局
Assessment of post-operative pain levels
时间窗: Post-operative pain levels assessed using the Visual Analog Scale (VAS) at 8 hours, 24 hours, and 48 hours after treatment.
Pain levels will be recorded using the Visual Analog Scale
时间窗: Post-operative pain levels assessed using the Visual Analog Scale (VAS) at 8 hours, 24 hours, and 48 hours after treatment.
次要结局
- To measure patient satisfaction with the treatment procedure, focusing on their comfort during & after the procedure(Patients will be asked to complete a structured survey or feedback form regarding their pain,comfort during treatment & overall satisfaction. The questionnaire will include questions on treatment comfort, post-treatment pain, & overall experience, rated on a Likert scale (e.g., 1–5, with 1 being very dissatisfied & 5 being very satisfied). after one week)
研究者
Dr Aishwarya Nivas Patil
School Of Dental Sciences,Krishna Vishwa Vidyapeeth Deemed to Be University