Postoperative Pain After Activation of Irrigant

Incidence of Postoperative Pain After Activation of Irrigant With Apical Negative Pressure and Ultrasonics in Mandibular Molar Teeth With Irreversible Pulpitis: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Device: Conventional root canal treatment; Device: Ultrasonic; Device: Apical negative pressure; Device: Combined Ultrasonic and negative pressure

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed A Hashem, PhD; Phone Number: 4405021591; Email: a.hashem@cdiohio.org
• Study Contact Backup: Name: Waleed Elmallah, PhD; Phone Number: 2163336695; Email: w.elmallah@cdiohio.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44128
      • Recruiting
      • Cleveland Dental Institute
      • Contact: Ahmed A Hashem, PhD; Phone Number: 440-502-1591; Email: a.hashem@cdiohio.org
      • Contact: Waleed Elmallah; Phone Number: 2163336695; Email: w.elmallah@cdiohio.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional root canal treatment; Irrigation will be performed with side vented needles only	Device: Conventional root canal treatment; Root canals will be irrigated by only side perforated needle
Experimental: Irrigant activation with Ultrasonic; Final irrigant activation will be done by ultrasonic	Device: Ultrasonic; Root canals will finally receive activation of the irrigant by the ultrasonic part of the IVAC system
Experimental: Irrigant activation with negative pressure; Final irrigant activation will be performed with apical negative pressure	Device: Apical negative pressure; Root canals will finally receive activation of the irrigant by the negative pressure part of the IVAC system
Experimental: Irrigant activation with both Ultrasonic and negative pressure; Final irrigation with a combination of ultrasonic and apical negative pressure using the IVAC device.	Device: Combined Ultrasonic and negative pressure; Root canals will finally receive activation of the irrigant by the IVAC system which is a combination of ultrasonic and apical negative pressure procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Scale (NRS)	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.	Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesics intake	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	6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.

Collaborators and Investigators

• Sponsor: Cleveland Dental Institute
• Investigators: Study Chair: Ahmed A Hashem, PhD, Cleveland Dental Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CDIENDO0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes