Evaluation of Post Operative Pain After Sonic Activation and Different Irrigation Needles During Root Canal Treatment (Endoactivator)

February 4, 2024 updated by: Ahmed Abdullah, Armed Forces Institute of Dentistry, Pakistan

Comparative Evaluation of Postoperative Pain After Using Endoactivator, Side Vented and Open Ended Endodontic Needles as Final Irrigation Protocols During Root Canal Treatment

The study compares the post operative pain after root canal therapy, after using different irrigation protocols. The subjects are divided into 3 groups and different irrigation protocol is used in each group. One group undergoes final irrigation after root canal therapy with a sonic activation device, and in the other two groups, side-vented and open-ended needles are used. Post operative pain is then compared at 8, 24, and 48 hour intervals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Root canal therapy is a procedure in which inflamed pulp tissue and microorganisms are removed from root canals and pulp chamber, in order to eradicate infection and symptoms. Irrigation is a crucial step of an endodontic therapy and different methods and protocols are used to enhance the efficacy of irrigation. Sonic activation of root canal irrigation agent is one of the effective methods that enhance the outcomes and success rate of endo therapies. It removes the smear layer, bacterial biofilms and debris by acoustic streaming and agitating the irrigant inside root canals. Similarly, irrigation needles also play an important role in endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of a root canal. conventionally, open ended needles have been used for irrigant delivery inside root canal but is not deemed very efficacious as they cannot penetrate deep into canals and cause extrusion of debris beyond the apex. This problem is solved by using side vented needles of smaller gauge (30 G) that leads to better irrigation and prevent extrusion of chemicals and debris outside the root apex.

In this study, the efficacy of all three different irrigation protocols will be compared and assessed based on post-operative pain, measured by Visual Analog Scale (VAS).

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 64000
        • Armed Forces Institute of dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients with unremarkable/ noncontributory medical history
  2. Healthy persons between the ages of 18 and 60 years
  3. Maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
  4. Patients not having taken any medication for 12 hours before treatment
  5. No allergies to the drugs or dental material being used in the treatment

Exclusion Criteria:

  1. Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours
  2. Pregnant women and patients with immunocompromised health state
  3. Patients having severe malocclusion associated with traumatic occlusion
  4. Teeth with calcified canals
  5. Teeth with periapical radiolucency
  6. Teeth with root resorption
  7. Teeth previously undergone root canal treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A - Open-ended needle
Open ended needle group. Irrigation in this group shall be done using a conventional open-ended needle during root canal therapy
Device: Open ended needle irrigation
irrigation during root canal shaping and cleaning using an open-ended needle
Experimental: Group B- side-vented needle
Side vented needle group. Irrigation in this group shall be done using a 30G side-vented needle during root canal therapy
Device: side vented needle irrigation
irrigation during root canal shaping and cleaning using a 30-guage side-vented needle
Experimental: Group C- Endoactivator
Sonic activation group. In this group, final irrigation during endodontic therapy shall be done using a sonic activation device (Endoactivator)
Device: Sonic activation
Agitation of root canal irrigation solution with a sonic activation device (Endoactivator).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative pain assessed by VAS after endodontic therapy
Time Frame: 1 week

comparative evaluation of post operative pain after using different irrigation devices, using VAS (Visual Analog Scale). It is drawn as a straight line of 10 inches and marked in numbers which show intensity of pain, from 0-10, with 0 being no pain at all to10 being the worst pain imaginable. In detail, it is a scale which shows pain intensity in ascending order and can also be used to analyze the intensity of pain experienced by the patient.

0: No pain at all 1-3: mild pain 4-6: moderate pain 7-9: severe pain 10: worst pain imaginable
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Institute of Dentistry, Pakistan

Investigators

  • Study Director: Athar Ali, BDS, Classified Specialist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

February 4, 2024

Study Completion (Actual)

February 4, 2024

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sonic activation

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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