Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID07357233

Impact of Manual-Less Root Canal Instrumentation Versus Conventional Rotary Instrumentation on Post Operative Pain and Neuropeptide Levels: Randomized Controlled Clinical Trial

Led by Alexandria University · Updated on 2026-01-21

34

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two root canal instrumentation methods to compare their effects on post-operative pain and the levels of certain neuropeptides, Substance P and Calcitonin gene-related peptide (CGRP). The study includes 34 permanent molars with symptomatic irreversible pulpitis and apical periodontitis. This research aims to explore how a manual-less technique, which skips manual scouting and glide path steps, compares to a conventional rotary technique in terms of pain and biochemical markers after treatment. Participants will be randomly assigned to one of two groups: the manual-less group, using rotary Dota files without scouting and glide path preparation, and the conventional group, which uses rotary Dota files following manual scouting and glide path creation with hand files. Levels of Substance P and CGRP will be measured before and after instrumentation using Elisa analysis. The study does not involve any masking or blinding. Participants will be monitored for post-operative pain at 6, 12, 24, 48, and 72 hours after the procedure. Pain levels will be assessed using a numeric rating scale. The correlation between post-operative pain and neuropeptide levels will also be analyzed, with samples collected immediately after instrumentation and at 72 hours. The study is expected to conclude by March 2026.

CONDITIONS

Brief Title

Comparison Between Two Instrumentation Techniques on Postoperative Pain and Level of Neuropeptides

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with symptomatic irreversible pulpitis and apical periodontitis in mandibular molars with closed apex
  • Healthy males and females (American Society of Anesthesiologists class I)
  • Age between 18 and 50 years old
  • Ability to understand and use the numeric rating scale for pain
  • No root resorption or abnormal anatomy on radiographs
  • Good oral hygiene and free from periodontal diseases
Not Eligible

You will not qualify if you...

  • Allergy to anesthetics
  • Pregnancy
  • Unrestorable teeth
  • Currently taking analgesics
  • Presence of root resorption or abnormal anatomy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single treatment session

Participants receive root canal instrumentation using either the manual-less rotary technique or the conventional rotary technique with scouting and glide path.

1 visit (in-person) for instrumentation and sample collection immediately post-procedure

Follow-up

Duration - 72 hours

Participants are monitored for post-operative pain and neuropeptide levels after treatment.

Visits at 6, 12, 24, 48, and 72 hours post-treatment for pain assessment and a final sample collection at 72 hours

Trial Site Locations

Total: 1 location

1

Alexandria Faculty of Dentistry

Alexandria, Egypt

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Research Team

H

hamdy Abou Almakarem, Msc

S

Sybel Moussa, PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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