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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: Manual-less; Other: Conventional technique

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hamdy Abou Almakarem, Msc; Phone Number: 01273805931; Email: hamdy.elwan.dent@alexu.edu.eg
• Study Contact Backup: Name: Sybel Moussa, PHD; Phone Number: 01223409497

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria Faculty of Dentistry
    • Contact: Hamdy m Abou Almakarem, BDS; Phone Number: 01273805931; Email: hamdy.elwan.dent@alexu.edu.eg
    • Principal Investigator: Hamdy m Abou Almakarem, msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Allergy to anesthetics.
2. Pregnancy
3. Unrestorable teeth.
4. Patient on analgesics.
5. Prescence of root resorption or abnormal anatomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: manual-less; Canals preparation with rotary dota files escaping scouting and glide path step.	Other: Manual-less; Canals preparation with rotary dota files escaping scouting and glide path step
Experimental: control; Canal preparation with rotary dota files with prior scouting and glide path with hand files.	Other: Conventional technique; Canal preparation with rotary drill files, with prior scouting and glide path with hand files.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between post operative pain and release of Substance P and Calcitonin gene-related peptide.	ELISA Kit will be used	first sample in the first visit immediatly post instrumentation ,second sample in the second visit72hr

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: root canal treatment; CGRP; Elisa; Time; irreversible pulpitis; manual-less technique; Substance p; controlled memory; apical fluids
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 928971

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No