Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:22 AM
Study NCT ID:
NCT07357233
Status:
RECRUITING
Last Update Posted:
2026-01-21
First Post:
2025-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Instrumentation Techniques on Postoperative Pain and Level of Neuropeptides
Sponsor:
Alexandria University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: