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临床试验/NCT07453134
NCT07453134进行中(未招募)不适用

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

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年11月7日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
Success and survival rate, Post-operative pain, OHIP-14 Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Conventional needle irrigation

No Intervention

Passive ultrasonic irrigation

Experimental

干预措施: root canal treatment and intracanal medicament (Procedure)

Laser-activated irrigation

Experimental

干预措施: root canal treatment and intracanal medicament (Procedure)

结局指标

主要结局

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

时间窗: "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.

次要结局

  • Prognostic factors affecting treatment outcomes("From enrollment to the end of treatment at 1 year")

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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