Symptomatic Irreversible Pulpitis and Symptomatic Apical PeriodontitisNCT07906808
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
A study testing diode laser activation irrigation and Ultrasonic irrigation activation in people with Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis, run by October 6 University at 1 site in Egypt.
Trial summary
The study is designed to determine whether activation of the irrigant using ultrasonic or diode laser technology can reduce postoperative pain and influence Substance P levels compared with conventional needle irrigation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
- What is being tested?
- diode laser activation irrigation and Ultrasonic irrigation activation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 15 Dec 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients ranging between 18 and 65 years in age .
- Patients that experienced moderate-to-severe pain (4-10)-represented on a visual analogue scale (VAS).
- Having a mandibular single rooted premolar tooth with vital pulp.
- Having the symptoms of symptomatic irreversible pulpitis and apical periodontitis.
Who cannot join
- Patients who were pregnant or lactating.
- Patients taking analgesic or anti-inflammatory drugs within the least 12 hours.
- Teeth with calcified root canals, resorptions.
- Previously root canal treated.
- severe damage and associated traumatic occlusion.
- Teeth with open apices.
- Presence of periodontal pockets >3 mm in the affected tooth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October 6 university
Giza
Mohsen Abielhasan, Dean, 0020238362488, Dean@o6u.edu.eg
About this study
Official title: The Effect of Ultrasonic and Diode Laser-Activated Irrigation on Postoperative Pain Reduction Following Conventional Root Canal Treatment: A Randomized Clinical Trial.
The study is designed to determine whether activation of the irrigant using ultrasonic or diode laser technology can reduce postoperative pain and influence Substance P levels compared with conventional needle irrigation. The findings may contribute to establishing evidence-based irrigation activation protocols for improving patient comfort following root canal treatment.
- Being tested
- diode laser activation irrigation, Ultrasonic irrigation activation
- Keywords
- Ultrasonic, Diode laser, Irrigation, Activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laser activation irrigationProcedure or surgery
This group will receive diode laser-activated irrigation using a 940-nm diode laser (Epic X, BIOLASE).
Ultrasonic irrigation activationProcedure or surgery
This group will receive ultrasonic-activated irrigation using the Ultra X ultrasonic activation device (Eighteeth).
| Study group | Role | What they receive |
|---|---|---|
| Conventional needle irrigation | No intervention | The control group will receive conventional needle irrigation during root canal treatment without additional irrigant activation. |
| Ultrasonic irrigation activation | Experimental | ultrasonic-activated irrigation using the Ultra X ultrasonic activation device (Eighteeth). Receives: Procedure: Ultrasonic irrigation activation |
| Diode laser irrigation activation | Experimental | This group will receive diode laser-activated irrigation using a 940-nm diode laser (Epic X, BIOLASE) Receives: Procedure: diode laser activation irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be assessed using a Visual Analog Scale (VAS) following conventional root canal treatment. Pain will be recorded at baseline before treatment and at predetermined postoperative time points to compare pain levels among the conventional needle irrigation, ultrasonic-activated irrigation using Ultra X, and 940-nm diode laser-activated irrigation using Epic X groups.
Measured: 12,24,48 hours
Secondary outcomes (1)
Substance P level
Substance P levels will be measured using an enzyme-linked immunosorbent assay (ELISA) to evaluate the effects of conventional needle irrigation, ultrasonic-activated irrigation using Ultra X, and 940-nm diode laser-activated irrigation using Epic X on Substance P levels. Measurements will be performed at the time points specified in the study protocol, and the results will be compared among the three study groups.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jun 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis and Symptomatic Apical PeriodontitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Hani Omaria, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906808
- Sponsor's protocol ID
- Reco6u/19-2026
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasonic and Diode Laser-Activated Irrigation on Postoperative Pain Reduction Following Conventional Root Canal Treatment: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07906808
- Acronym / sponsor ID
- Reco6u/19-2026
- Keywords
- Ultrasonic, Diode laser, Irrigation, Activation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 30 Oct 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.
The study is designed to determine whether activation of the irrigant using ultrasonic or diode laser technology can reduce postoperative pain and influence Substance P levels compared with conventional needle irrigation. The findings may contribute to establishing evidence-based irrigation activation protocols for improving patient comfort following root canal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional needle irrigation | No intervention | –The control group will receive conventional needle irrigation during root canal treatment without additional irrigant activation. |
| Ultrasonic irrigation activation | Experimental | Procedure: Ultrasonic irrigation activationultrasonic-activated irrigation using the Ultra X ultrasonic activation device (Eighteeth). |
| Diode laser irrigation activation | Experimental | Procedure: diode laser activation irrigationThis group will receive diode laser-activated irrigation using a 940-nm diode laser (Epic X, BIOLASE) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy patients ranging between 18 and 65 years in age .
- Patients that experienced moderate-to-severe pain (4-10)-represented on a visual analogue scale (VAS).
- Having a mandibular single rooted premolar tooth with vital pulp.
- Having the symptoms of symptomatic irreversible pulpitis and apical periodontitis.
Key exclusion criteria (7 listed)
- Patients who were pregnant or lactating.
- Patients taking analgesic or anti-inflammatory drugs within the least 12 hours.
- Teeth with calcified root canals, resorptions.
- Previously root canal treated.
- severe damage and associated traumatic occlusion.
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 |
|---|---|---|
| diode laser activation irrigationThis group will receive diode laser-activated irrigation using a 940-nm diode laser (Epic X, BIOLASE). | Procedure or surgery | Diode laser irrigation activation |
| Ultrasonic irrigation activationThis group will receive ultrasonic-activated irrigation using the Ultra X ultrasonic activation device (Eighteeth). | Procedure or surgery | Ultrasonic irrigation activation |
Primary outcome
Postoperative pain
Time frame: 12,24,48 hours
Postoperative pain will be assessed using a Visual Analog Scale (VAS) following conventional root canal treatment. Pain will be recorded at baseline before treatment and at predetermined postoperative time points to compare pain levels among the conventional needle irrigation, ultrasonic-activated irrigation using Ultra X, and 940-nm diode laser-activated irrigation using Epic X groups.
1 secondary outcome
Substance P level
Time frame: up to 24 hours
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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diode laser activation irrigation and Ultrasonic irrigation activation in people with Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis, run by October 6 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 4 inclusion and 7 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 30 Oct 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 Alaa Hani Omaria, Master degree candidate (00201507070244, Omariaalaa86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 12,24,48 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 30 Oct 2026.