Cbct based comparative evaluation of avulsed teeth replantation outcomes : influence of extra-oral time and storage medium
概览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- Saveetha Dental College, SIMATS University
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 1. Closure of open apex
概览
简要总结
This study evaluates the outcomes of replantation in cases of avulsed permanent teeth treated with extraoral root canal treatment (RCT), using cone-beam computed tomography (CBCT) for precise assessment. A cluster randomized trial design is employed, with dental trauma care centers as clusters. Centers are randomized to different standardized management protocols, such as variations in extraoral dry time, storage medium, and replantation techniques. The study includes patients aged 9-14 years with a history of traumatic avulsion and extraoral dry time. Only cases with proper replantation protocols and consent for post-operative CBCT imaging are included. Outcomes focus on periapical healing, root resorption, and periodontal health, with a minimum follow-up of 6-12 months. Clusters implement assigned protocols, ensuring uniformity within centers while allowing comparison across groups. Statistical analysis accounts for clustering effects, using hierarchical models to evaluate the impact of management strategies on clinical and radiographic outcomes. By integrating CBCT imaging with a cluster randomized approach, the study aims to enhance evidence-based protocols for avulsed tooth management, improving long-term treatment success and patient care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 9.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •Children attending clinic with avulsed teeth and requires emergency management.
- •Children parents willing to undergo followup CBCT imaging for periapical evaluation following trauma and follow up for 12 months.
- •Cases where root canal treatment required before doing replantation.
- •Parents willing for informed consent.
排除标准
- •Children with systemic condition or medication that affect healing example diabetes or immunosuppressant drugs.
- •Parents not willing for CBCT imaging.
- •Childrens with extensive orofacial trauma.
- •Parents not following up with follow up.
- •Poor quality of CBCT image or artifact.
结局指标
主要结局
1. Closure of open apex
时间窗: Baseline, 6 months, 12 months
2. Root resorption evaluation.
时间窗: Baseline, 6 months, 12 months
3. Tooth mobiility.
时间窗: Baseline, 6 months, 12 months
4. Periapical healing.
时间窗: Baseline, 6 months, 12 months
5. Quality of life.
时间窗: Baseline, 6 months, 12 months
次要结局
- 1. Extra oral dry time(2. Storage medium)
研究者
Harsh Sanjaykumar Baldawa
Saveetha Dental College, SIMATS University