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

NCT06777381 | Enrolling By Invitation

• 1 other identifier: 03460224
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

post-operative pain; ProTaper; M-Pro; single visit

Outcome Measures

Primary Outcomes (1)

• Record the intensity of postoperative pain after root canal treatment with ProTaper Universal and M-Pro endodontic rotary files.

  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

Study Arms (2)

Group A: ProTaper Universal system

EXPERIMENTAL

root canal treatment will be performed in single visit using ProTaper Universal system

Procedure: single visit root canal treatment using ProTaper Universal rotary system

Group B: M-Pro rotary system

EXPERIMENTAL

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

Interventions

single visit root canal treatment using ProTaper Universal rotary system PROCEDURE

single visit endodontic treatment will be performed using ProTaper Universal rotary system for root canal preparation.

Group A: ProTaper Universal system

single visit root canal treatment using M-Pro rotary system PROCEDURE

single visit endodontic treatment will be performed using MPro rotary systems for root canal preparation.

Group B: M-Pro rotary system

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

Dental Clinic at Medical Research Centre of Excellence, National Research Centre

Cairo, Egypt

Location

Related Publications (1)

• Khallaf ME, Aly Y, Mohamed AI. Comparison of post-operative pain prevalence after single visit endodontic treatment with two NiTi rotary files - a randomized clinical trial. Sci Rep. 2025 Dec 18;15(1):44128. doi: 10.1038/s41598-025-29029-8.

  PMID: 41413418 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 15, 2025
• Study Start: October 25, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)