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

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.

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Key information

Conditions

Root Canal Treatment Irrigation Activation Neurologic Manifestations Oral Health Quality of Life (OHQoL) Was Assessed Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain After Root Canal Therapy Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

root canal treatment and intracanal medicament

Procedure

Laser-activated irrigation

Primary outcomes

Success and survival rate, Post-operative pain, OHIP-14 Score

Time frame: "From enrollment to the end of treatment at 1 year"
- 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.

Secondary outcomes

Prognostic factors affecting treatment outcomes

Time frame: "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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Mar 5, 2026
Registry last updated: Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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