Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment

January 10, 2025 updated by: Amira lbrahim Mohamed, National Research Centre, Egypt

Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment with Two NiTi Rotary Files - a Randomized Clinical Trial

The goal of this clinical trial is to compare the post-operative pain occurrence after single visit root canal treatment using Two NiTi Rotary Files. The main question it aims to answer is:

• Does an instrument design and instrumentation technique could affect postoperative pain incidence and intensity? Researchers will use ProTaper Universal rotary system or M-Pro rotary system for root canal preparation and compared postoperative pain intensity.

Participants will receive single visit endodontic treatment using either ProTaper or MPro systems for root canal preparation.

Participants will record Pain intensity at 24 hours and 7 days post-operative. Analgesics will be prescribed for the patients in need.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The main cause of patient fear is expecting pain during root canal treatment. It is considered a major concern for dentists as well. During root canal preparation, periapical extrusion of pulpal tissue remnants, microorganisms or dentin chips may be one of the causes of postoperative pain. Depending on the fact that, instrument design and instrumentation techniques have an impact on the amount of extruded debris apically, many studies proved the ability of some rotary systems to reduce debris extrusion, permitting to achieve less pain sensation.

Therefore, the present clinical study aims to compare the postoperative pain intensity in molars with symptomatic irreversible pulpitis after single endodontic treatment visit using a full-sequence rotary Ni-Ti system either ProTaper or MPro systems Eighty patients with symptomatic irreversible pulpitis in mandibular first molars will be assigned into two groups. In group A (n=40): root canal preparation will be performed in single visit using ProTaper Universal system and in group B (n=40): root canal preparation will be performed in single visit using M-Pro rotary system. Pain intensity will be recorded by the patient using Numerical Rating Scale (NRS) at 24 hours and 7 days postoperative. Analgesics will be prescribed for the patients in case of need.

Study Type

Interventional

Enrollment (Estimated)

80

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 Locations

  • Egypt
      • Cairo, Egypt
        • Dental Clinic at Medical Research Centre of Excellence, National Research Centre

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient's diagnosis is symptomatic irreversible pulpitis in mandibular first molar.
  • Males and females patients in a good health.
  • Aged from 25 to 45 years old.
  • Pulp vitality is confirmed with cold pulp test and an electric pulp test.

Exclusion Criteria:

  • Pregnant females.
  • Patients complaining from pain in more than one molar on the same side.
  • Patients whose teeth react positively to percussion test.
  • Patients who receive analgesics 12 hours before the start of the root canal treatment.
  • Teeth having grade 2 or 3 mobility.
  • Presence of periapical radiolucency or teeth with extra oral or intraoral sinus tract or fistula.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: ProTaper Universal system
root canal treatment will be performed in single visit using ProTaper Universal system
Procedure: single visit root canal treatment using ProTaper Universal rotary system
single visit endodontic treatment will be performed using ProTaper Universal rotary system for root canal preparation.
Experimental: Group B: M-Pro rotary system
root canal treatment will be performed in single visit using M-Pro rotary system
Procedure: single visit root canal treatment using M-Pro rotary system
single visit endodontic treatment will be performed using MPro rotary systems for root canal preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record the intensity of postoperative pain after root canal treatment with ProTaper Universal and M-Pro endodontic rotary files.
Time Frame: 7 days
Pain intensity will be recorded by the patient 24 hours and 7 days postoperatively. Pain assessment is evaluated using 10-point Numerical Rating Scale, where the endpoints are the extremes of no pain and worst pain. The severity of pain is assigned as follows: (0) equivalent to none/ (1) equivalent to slight pain / (2) equivalent to moderate pain and (3) equivalent to severe pain.
7 days

Collaborators and Investigators

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

Sponsor

National Research Centre, Egypt

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)

October 25, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 29, 2024

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03460224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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