Postoperative Pain After Activation of Irrigant

Not Applicable

Recruiting

• Conditions: Pain
• Interventions: Device: Apical negative pressure; Device: Conventional root canal treatment; Device: Ultrasonic; Device: Combined Ultrasonic and negative pressure

• Registration Number: NCT06528574
• Lead Sponsor: Cleveland Dental Institute

Brief Summary

The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques.

PICOTS Question:

Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain

By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure.

pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Males and females Age :20-50 Mandibular mature first molars with symptomatic acute pulpitis Medically free patients

Exclusion Criteria

Pulp necrosis or apical periodontitis Periodontal disease Vertical root fracture Radiographic apical radiolucency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irrigant activation with negative pressure	Apical negative pressure	Final irrigant activation will be performed with apical negative pressure
Conventional root canal treatment	Conventional root canal treatment	Irrigation will be performed with side vented needles only
Irrigant activation with Ultrasonic	Ultrasonic	Final irrigant activation will be done by ultrasonic
Irrigant activation with both Ultrasonic and negative pressure	Combined Ultrasonic and negative pressure	Final irrigation with a combination of ultrasonic and apical negative pressure using the IVAC device.

Primary Outcome Measures

Name	Time	Method
Numerical Pain Scale (NRS)	Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.	Pain will be assessed during the numerical rate scale (NRS) which has a scale from 0 to 10, where 0 is no pain while 10 is most unbearable one.

Secondary Outcome Measures

Name	Time	Method
Analgesics intake	6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.	The patient will be advised to take analgesics in case of unbearable pain and record this. Number of tablets and the time will be recorded; ● The satisfaction of patients regarding the pain management intervention at the follow-up

Trial Locations

Locations (1)

Cleveland Dental Institute; 🇺🇸 Cleveland, Ohio, United States