Post Operative PainNCT07357233
Comparison Between Two Instrumentation Techniques on Postoperative Pain and Level of Neuropeptides
A study testing Manual-less and Conventional technique in people with Post Operative Pain, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Manual-less and Conventional technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Allergy to anesthetics.
- Pregnancy
- Unrestorable teeth.
- Patient on analgesics.
- Prescence of root resorption or abnormal anatomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sybel Moussa, PHD contact
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Hamdy m Abou Almakarem, BDS, 01273805931, hamdy.elwan.dent@alexu.edu.eg
Hamdy m Abou Almakarem, msc
About this study
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
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.
Read the 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
- Being tested
- Manual-less, Conventional technique
- Keywords
- manual-less technique, Substance p, CGRP, root canal treatment, irreversible pulpitis, controlled memory, apical fluids, Elisa, Time
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual-lessOther
Canals preparation with rotary dota files escaping scouting and glide path step
Conventional techniqueOther
Canal preparation with rotary drill files, with prior scouting and glide path with hand files.
| Study group | Role | What they receive |
|---|---|---|
| manual-less | Experimental | Canals preparation with rotary dota files escaping scouting and glide path step. Receives: Other: Manual-less |
| control | Experimental | Canal preparation with rotary dota files with prior scouting and glide path with hand files. Receives: Other: Conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post operative pain
Numeric rating scale ranges from zero to 10. zero means no pain and 10 means severe pain.
Measured: 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.
ELISA Kit will be used
Measured: first sample in the first visit immediatly post instrumentation ,second sample in the second visit72hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Sep 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357233
- Sponsor's protocol ID
- 928971
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07357233
- Acronym / sponsor ID
- 928971
- Conditions
- Post Operative Pain
- Keywords
- manual-less technique, Substance p, CGRP, root canal treatment, irreversible pulpitis, controlled memory, apical fluids, Elisa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual-less | Experimental | Other: Manual-lessCanals preparation with rotary dota files escaping scouting and glide path step. |
| control | Experimental | Other: Conventional techniqueCanal preparation with rotary dota files with prior scouting and glide path with hand files. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Allergy to anesthetics.
- Pregnancy
- Unrestorable teeth.
- Patient on analgesics.
- Prescence of root resorption or abnormal anatomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual-lessCanals preparation with rotary dota files escaping scouting and glide path step | Other | manual-less |
| Conventional techniqueCanal preparation with rotary drill files, with prior scouting and glide path with hand files. | Other | control |
Primary outcome
Change in post operative pain
Time frame: 6 hours,12 hours,24 hours,48 hours,72 hours
Numeric rating scale ranges from zero to 10. zero means no pain and 10 means severe pain.
1 secondary outcome
correlation between post operative pain and release of Substance P and Calcitonin gene-related peptide.
Time frame: first sample in the first visit immediatly post instrumentation ,second sample in the second visit72hr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sybel Moussa, PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual-less and Conventional technique in people with Post Operative Pain, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hamdy Abou Almakarem, Msc (01273805931, hamdy.elwan.dent@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post operative pain (time frame: 6 hours,12 hours,24 hours,48 hours,72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.