NCT07357233

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
OTHER	Manual-less	Canals preparation with rotary dota files escaping scouting and glide path step
OTHER	Conventional technique	Canal preparation with rotary drill files, with prior scouting and glide path with hand files.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: Egypt