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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Chulalongkorn University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Success and survival rate, Post-operative pain, OHIP-14 Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Conventional needle irrigation
Passive ultrasonic irrigation
Intervention: root canal treatment and intracanal medicament (Procedure)
Laser-activated irrigation
Intervention: root canal treatment and intracanal medicament (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Prognostic factors affecting treatment outcomes("From enrollment to the end of treatment at 1 year")