Root Canal TreatmentNCT07453134
Treatment Outcome and Patient-reported Outcomes in Patient Undergoing Non-surgical Root Canal Treatment With Different Irrigation Protocols
A study testing root canal treatment and intracanal medicament in people with Root Canal Treatment and Irrigation Activation, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to evaluate and compare the clinical and patient-reported outcomes of passive ultrasonic irrigation (PUI) and laser-activated irrigation (LAI) versus conventional syringe irrigation in adult patients undergoing non-surgical root canal treatment on mature permanent teeth, and to identify the key factors… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Treatment, Irrigation Activation, Oral Health Quality of Life (OHQoL) Was Assessed
- What is being tested?
- root canal treatment and intracanal medicament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- 7 Nov 2025to 30 Apr 2028
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All permanent teeth diagnosed with any of the following conditions including irreversible pulpitis (symptomatic and asymptomatic), pulp necrosis, previously initiated therapy with or without apical periodontitis o Patients with age 18-80
- Patients with Thai ethnicity
- Patients who could read and communicate in Thai language
- Patients with well-controlled medical conditions according to ASA I and II classification
Who cannot join
- The tooth with cracks, incomplete root formation, vertical or horizontal root fractures or root resorption
- The tooth with periodontal pocket depth of 5 mm or more, degree of mobility of 2 or more
- Patients with bone metabolism disease and/or using steroids or bisphosphonates, immunosuppressed, history of radiotherapy, pregnancy o Patients with serious medical conditions that required consultation with a physician before root canal treatment
- Patients who refuse to participate or could not answer the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Outcome and Impact on Oral Health-related Quality of Life in Patient Undergoing Non-surgical Root Canal Treatment With Different Irrigation Protocols: Randomized Clinical Trial
This study aims to evaluate and compare the clinical and patient-reported outcomes of passive ultrasonic irrigation (PUI) and laser-activated irrigation (LAI) versus conventional syringe irrigation in adult patients undergoing non-surgical root canal treatment on mature permanent teeth, and to identify the key factors that influence these outcomes.
- Conditions
- Root Canal Treatment, Irrigation Activation, Oral Health Quality of Life (OHQoL) Was Assessed, Post Operative Pain After Root Canal Therapy
- Being tested
- root canal treatment and intracanal medicament
- Keywords
- Laser-activated Irrigation, Oral Health-Related Quality of Life, Post-Operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal treatment and intracanal medicamentProcedure or surgery
Laser-activated irrigation
root canal treatment and intracanal medicamentProcedure or surgery
Passive ultrasonic irrigation
| Study group | Role | What they receive |
|---|---|---|
| Conventional needle irrigation | No intervention | Not described |
| Passive ultrasonic irrigation | Experimental | Not described Receives: Procedure: root canal treatment and intracanal medicament |
| Laser-activated irrigation | Experimental | Not described Receives: Procedure: root canal treatment and intracanal medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success and survival rate, Post-operative pain, OHIP-14 Score
- Success rate At the 1-year follow-up visit, the dentist will perform a clinical and radiographic examination, A calibrated researcher that blinded to the treatment procedures and irrigation activation methods, will interpret the radiographs using the criteria established by Friedman and Mor (2004)
- Survival rate = Tooth is functional and remains in the mouth.
- Post-operative pain will be assessed using the Numerical Rating Scale (NRS), with scores recorded before treatment (baseline) and after complete treatment. In cases treated over two visits, pain scores will be record
- Oral health-related quality of life will be evaluated using the OHIP-14 questionnaires recorded before treatment (baseline) and after complete treatment.
Measured: "From enrollment to the end of treatment at 1 year"
Secondary outcomes (1)
Prognostic factors affecting treatment outcomes
Some factors associated to treatment outcomes will be analyzed such as age, gender, tooth type, tooth diagnosis, activated irrigation methods, quality of root canal treatment, quality of coronal restoration
Measured: "From enrollment to the end of treatment at 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start7 Nov 2025
- Primary completion6 Nov 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal TreatmentStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453134
- Sponsor's protocol ID
- HREC-DCU 2025-148
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome and Impact on Oral Health-related Quality of Life in Patient Undergoing Non-surgical Root Canal Treatment With Different Irrigation Protocols: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07453134
- Acronym / sponsor ID
- HREC-DCU 2025-148
- Conditions
- Root Canal Treatment, Irrigation Activation, Oral Health Quality of Life (OHQoL) Was Assessed, Post Operative Pain After Root Canal Therapy
- Keywords
- Laser-activated Irrigation, Oral Health-Related Quality of Life, Post-Operative pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 6 Nov 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 5 Mar 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.
This study aims to evaluate and compare the clinical and patient-reported outcomes of passive ultrasonic irrigation (PUI) and laser-activated irrigation (LAI) versus conventional syringe irrigation in adult patients undergoing non-surgical root canal treatment on mature permanent teeth, and to identify the key factors that influence these outcomes.
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 | – |
| Passive ultrasonic irrigation | Experimental | Procedure: root canal treatment and intracanal medicament |
| Laser-activated irrigation | Experimental | Procedure: root canal treatment and intracanal medicament |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All permanent teeth diagnosed with any of the following conditions including irreversible pulpitis (symptomatic and asymptomatic), pulp necrosis, previously initiated therapy with or without apical periodontitis o Patients with age 18-80
- Patients with Thai ethnicity
- Patients who could read and communicate in Thai language
- Patients with well-controlled medical conditions according to ASA I and II classification
Key exclusion criteria (4 listed)
- The tooth with cracks, incomplete root formation, vertical or horizontal root fractures or root resorption
- The tooth with periodontal pocket depth of 5 mm or more, degree of mobility of 2 or more
- Patients with bone metabolism disease and/or using steroids or bisphosphonates, immunosuppressed, history of radiotherapy, pregnancy o Patients with serious medical conditions that required consultation with a physician before root canal treatment
- Patients who refuse to participate or could not answer the questionnaires
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 |
|---|---|---|
| root canal treatment and intracanal medicamentLaser-activated irrigation | Procedure or surgery | Laser-activated irrigation |
| root canal treatment and intracanal medicamentPassive ultrasonic irrigation | Procedure or surgery | Passive ultrasonic irrigation |
Primary outcome
Success and survival rate, Post-operative pain, OHIP-14 Score
Time frame: "From enrollment to the end of treatment at 1 year"
1. Success rate At the 1-year follow-up visit, the dentist will perform a clinical and radiographic examination, A calibrated researcher that blinded to the treatment procedures and irrigation activation methods, will interpret the radiographs using the criteria established by Friedman and Mor (2004) - Survival rate = Tooth is functional and remains in the mouth. 2. Post-operative pain will be assessed using the Numerical Rating Scale (NRS), with scores recorded before treatment (baseline) and after complete treatment. In cases treated over two visits, pain scores will be record 3. Oral health-related quality of life will be evaluated using the OHIP-14 questionnaires recorded before treatment (baseline) and after complete treatment.
1 secondary outcome
Prognostic factors affecting treatment outcomes
Time frame: "From enrollment to the end of treatment at 1 year"
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 5 Mar 2026.
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal treatment and intracanal medicament in people with Root Canal Treatment and Irrigation Activation, run by Chulalongkorn University at 1 site in Thailand.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 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 Thailand. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success and survival rate, Post-operative pain, OHIP-14 Score (time frame: "From enrollment to the end of treatment at 1 year"). 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 5 Mar 2026.