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
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.
- 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