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CompletedNCT04216940Updated Jan 3, 2020

Pain Intensity After Root Canal Instrumentation

An interventional study of mechanical preparation of root canal system in Pain, Postoperative, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-03.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2019, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
25 Years to 40 Years
Sex
All
01

Study summary

Assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after instrumentation with two rotary systems Mpro and Hyflex files.

02

Conditions studied

  • Pain, Postoperative
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 50 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • mandibular molars with acute pulpitis

Exclusion criteria

Exclusion Criteria:

  • badly decayed non-restorable molars
  • medically compromised patients
05

Study design

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

Study arms

  • Experimental
    M-pro

    Device: mechanical preparation of root canal system

  • Experimental
    Hyflex

    Device: mechanical preparation of root canal system

Interventions

  • Devicemechanical preparation of root canal system

    Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems

06

What researchers measure

Primary outcomes

  1. Pain felt after mechanical instrumentation in the first visit

    using Numeric Rating Scale (NRS) the participant will be asked to verbally rate their pain on a scale from 0 to 10, with 0 equal to no pain and 10 equal to worst possible pain

    Time frame: up to 72 hours

07

Study locations

1 site
  • Ain Shams University
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04216940
Lead sponsor
Ain Shams University
Responsible party
Maram Obeid (Ass. Prof., Ain Shams University) — Principal investigator
First posted
Jan 3, 2020
Start date
Feb 10, 2019
Primary completion
Aug 28, 2019
Completion
Aug 28, 2019
Last update
Jan 3, 2020

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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