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

NCT07453134 | Active Not Recruiting

• 1 other identifier: HREC-DCU 2025-148
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain After Root Canal Therapy; Root Canal Treatment; Irrigation Activation; Oral Health Quality of Life (OHQoL) Was Assessed

Keywords

Laser-activated Irrigation; Oral Health-Related Quality of Life; Post-Operative pain

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Prognostic factors affecting treatment outcomes

  "From enrollment to the end of treatment at 1 year"

Study Arms (3)

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

Interventions

root canal treatment and intracanal medicament PROCEDURE

Laser-activated irrigation

Laser-activated irrigation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 5, 2026
• Study Start: November 7, 2025
• Primary Completion (Estimated): November 6, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

TH (1)