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

NCT07357233 | Recruiting

• 1 other identifier: 928971
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Keywords

manual-less technique; Substance p; CGRP; root canal treatment; irreversible pulpitis; controlled memory; apical fluids; Elisa; Time

Outcome Measures

Primary Outcomes (1)

• Change in post operative pain

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

  6 hours,12 hours,24 hours,48 hours,72 hours

Secondary Outcomes (1)

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

  first sample in the first visit immediatly post instrumentation ,second sample in the second visit72hr

Study Arms (2)

manual-less

EXPERIMENTAL

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

Other: Manual-less

control

EXPERIMENTAL

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

Other: Conventional technique

Interventions

Manual-less OTHER

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

manual-less

Conventional technique OTHER

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

control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

hamdy Abou Almakarem, Msc

CONTACT

01273805931; hamdy.elwan.dent@alexu.edu.eg

Sybel Moussa, PHD

CONTACT

01223409497

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 21, 2026
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-12

Locations

EG (1)