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NCT Number: NCT07357233

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

General aim: assessment of post operative pain and time of preparation with the execution of manual-less technique and conventional technique.

Specific aim: correlation between post operative pain and release of Substance P and Calcitonin gene-related peptide.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location status: Recruiting

Location contact

Hamdy m Abou Almakarem, BDS

CONTACT

[email protected]

01273805931

Hamdy m Abou Almakarem, msc

PRINCIPAL_INVESTIGATOR

About this study

Background: Post-operative pain (POP) remains a significant challenge after root canal treatment. A recent approach emphasizes objective pain assessment by measuring neuropeptides like substance P (SP) and calcitonin gene-related peptide (CGRP). Rotary nickel-titanium (NiTi) instruments have largely replaced manual stainless-steel files, improving efficiency, maintaining original root canal anatomy and reducing errors. Advances such as controlled memory (CM) files help minimize debris extrusion, potentially lowering POP. A fully rotary approach, eliminating the need for manual scouting and glide path creation, could offer a faster, more predictable alternative. This approach could be named as manual-less technique.

Aim: This study compares between manual-less instrumentation technique (excluding scouting and glide path step) versus conventional rotary instrumentation technique on the post operative pain and release of SP and CGRP.

Materials and methods: A total of 34 permanent molars with symptomatic irreversible pulpitis and apical periodontitis will be included in this study. They will be randomly divided into 2 groups (n=17): group I(manual-less): canal preparation using Dota rotary files escaping scouting and glide path step and Group II (conventional): canal preparation using Dota rotary files with prior scouting and glide path with hand files. Elisa analysis will be done for measuring level of SP and CGRP before and after instrumentation.

Analysis: All data will be collected and statistically analyzed with the appropriate statistical tests.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptomatic irreversible pulpitis and apical periodontitis in mandibular molars with closed apex.(17)
  • Healthy males and females (Category: American Society of Anesthesiologists class I).
  • Age of patients range from 18 to 50 years old.
  • Those who could understand the use of the numeric rating scale (NRS) for pain.
  • In cases where radiographs show no root resorption or abnormal anatomy.
  • Patients with good oral hygiene and free from periodontal diseases.

Exclusion criteria

  • Allergy to anesthetics.
  • Pregnancy
  • Unrestorable teeth.
  • Patient on analgesics.
  • Prescence of root resorption or abnormal anatomy.

Treatment and study plan

Manual-less

Other

Canals preparation with rotary dota files escaping scouting and glide path step

Conventional Technique

Other

Canal preparation with rotary drill files, with prior scouting and glide path with hand files.

Primary outcomes

  1. Change in post operative pain

    Time frame: 6 hours,12 hours,24 hours,48 hours,72 hours

    Numeric rating scale ranges from zero to 10. zero means no pain and 10 means severe pain.

Secondary outcomes

  1. correlation between post operative pain and release of Substance P and Calcitonin gene-related peptide.

    Time frame: first sample in the first visit immediatly post instrumentation ,second sample in the second visit72hr

    ELISA Kit will be used

Study contacts

Contact information is provided by the study sponsor or research team.

Sybel Moussa, PHD

CONTACT

01223409497

hamdy Abou Almakarem, Msc

CONTACT

[email protected]

01273805931

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Impact Of Manual-Less Root Canal Instrumentation Versus Conventional Rotary Instrumentation On Post Operative Pain And Level Of Neuropeptides: Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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