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Treatment Outcome and Patient-reported Outcomes in Patient Undergoing Non-surgical Root Canal Treatment With Different Irrigation Protocols

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07453134
Enrollment
90
Registered
2026-03-05
Start date
2025-11-07
Completion date
2028-04-30
Last updated
2026-03-05

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

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

Brief 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 that influence these outcomes.

Interventions

Laser-activated irrigation

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Success and survival rate, Post-operative pain, OHIP-14 Score"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.

Secondary

MeasureTime frameDescription
Prognostic factors affecting treatment outcomes"From enrollment to the end of treatment at 1 year"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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026