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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07357233
Enrollment
34
Registered
2026-01-21
Start date
2025-09-01
Completion date
2026-03-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

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

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.

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.

Interventions

OTHERManual-less

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

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in post operative pain6 hours,12 hours,24 hours,48 hours,72 hoursNumeric rating scale ranges from zero to 10. zero means no pain and 10 means severe pain.

Secondary

MeasureTime frameDescription
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 visit72hrELISA Kit will be used

Countries

Egypt

Contacts

CONTACThamdy Abou Almakarem, Msc
hamdy.elwan.dent@alexu.edu.eg01273805931
CONTACTSybel Moussa, PHD
01223409497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026