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

March 3, 2026 updated by: Chulalongkorn University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional needle irrigation
Experimental: Passive ultrasonic irrigation
Procedure: root canal treatment and intracanal medicament
Laser-activated irrigation
Procedure: root canal treatment and intracanal medicament
Passive ultrasonic irrigation
Experimental: Laser-activated irrigation
Procedure: root canal treatment and intracanal medicament
Laser-activated irrigation
Procedure: root canal treatment and intracanal medicament
Passive ultrasonic irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
"From enrollment to the end of treatment at 1 year"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
"From enrollment to the end of treatment at 1 year"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

November 6, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC-DCU 2025-148

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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