A Comparative Evaluation of Two Different Diode Laser Wavelengths and Conventional Root Canal Disinfection in Pulp Regeneration of Necrotic Immature Permanent Teeth – A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Radiographic Success Rate will be assessed Root-width/legth ratio, Nollas stage of tooth development, Dentin wall thickness, Root Length, apical diameter, diameter of the periapical radiolucency if present, perforation if present
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate and compare the clinical, radiographic, and antimicrobial efficacy of three different root canal disinfection protocols—Triple Antibiotic Paste (TAP), 810 nm diode laser, and 980 nm diode laser—in the context of pulp revascularization for necrotic immature permanent anterior teeth in children. Pulp revascularization, a regenerative endodontic approach, offers a biologically based treatment for teeth with open apices. The success of this technique depends heavily on effective disinfection while preserving the viability of stem cells in the apical papilla.
The study will involve 30 children aged 7–9 years with non-vital, immature maxillary central incisors. Participants will be randomly divided into three groups (n=10 per group). Group 1 will receive TAP for 3 weeks; Group 2 will undergo disinfection using an 810 nm diode laser; Group 3 will receive 980 nm diode laser treatment. Microbial samples will be collected pre- and post-disinfection to evaluate the reduction in colony-forming units (CFUs). All groups will follow the American Association of Endodontists (AAE) 2021 protocol for regenerative endodontics.
Clinical and radiographic outcomes, including root length, dentin wall thickness, apical closure, and post-operative symptoms, will be assessed at 3, 6, 9, and 12 months. A final CBCT scan at 12 months will help evaluate root development and healing. Statistical analysis will be performed using SPSS v25, with appropriate tests based on data distribution.
This study is expected to provide valuable insights into the most biologically favorable and clinically effective disinfection strategy for regenerative endodontics. The findings will contribute to improved protocols for managing necrotic immature permanent teeth in pediatric patients, enhancing both treatment success and long-term prognosis. Ethical clearance has been obtained for this low-risk clinical trial involving children and minimally invasive procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •subjects who come under ASA I for children
- •children of both genders with an age range from 7 to 9 years
- •The tooth in question is in a restorable state
- •Permanent necrotic central incisors with incomplete root development defined by apical foramen size greater than 1 mm
- •subjected to any line of endodontic treatment.
排除标准
- •root resorption , ankylosis and root fracture
- •uncooperative patients
- •legal guardians did not consent to participate in the study
- •presence of draining sinus and presence of periodontal pockets,
- •presence of periapical radiolucency more than 10mm measured using DBSWIN software tool.
结局指标
主要结局
The Radiographic Success Rate will be assessed Root-width/legth ratio, Nollas stage of tooth development, Dentin wall thickness, Root Length, apical diameter, diameter of the periapical radiolucency if present, perforation if present
时间窗: All the above parameters will be assessed at baseline, 3rd, 6th and 12th months interval using cbct and rvg alternatively
次要结局
- the clinical success rate will be assessed Vitality, post operative pain, swelling, tooth discolouration, mobility and tender on percussion.(All the above parameters will be assessed at baseline, 3rd, 6th and 12th months interval)
研究者
Dr Priyanka B
Chettinad Dental College and Reseach Institute