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Enrolling by invitationNCT06777381Updated Jan 15, 2025

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

An interventional study of single visit root canal treatment using ProTaper Universal rotary system and single visit root canal treatment using M-Pro rotary system in Symptomatic Irreversible Pulpitis, sponsored by National Research Centre, Egypt. Enrolling by invitation at 1 site in Egypt. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by National Research Centre, Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Symptomatic Irreversible Pulpitis

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Keywords

  • post-operative pain
  • ProTaper
  • M-Pro
  • single visit
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

National Research Centre, Egypt is the lead sponsor of 51 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Proceduresingle 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.

  • Proceduresingle visit root canal treatment using M-Pro rotary system

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

06

What researchers measure

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.

    Time frame: 7 days

07

Study locations

1 site
  • Dental Clinic at Medical Research Centre of Excellence, National Research Centre
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06777381
Lead sponsor
National Research Centre, Egypt
Responsible party
Amira lbrahim Mohamed (Researcher, National Research Centre, Egypt) — Principal investigator
First posted
Jan 15, 2025
Start date
Oct 25, 2024
Primary completion
Feb 2025 (estimated)
Completion
Feb 2025 (estimated)
Last update
Jan 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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