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临床试验/CTRI/2024/12/077738
CTRI/2024/12/077738
尚未招募
Phase 3 4

Cbct based comparative evaluation of avulsed teeth replantation outcomes : influence of extra-oral time and storage medium

Saveetha Dental College, SIMATS University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年12月17日最近更新:

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

发起方
Saveetha Dental College, SIMATS University
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Harsh Sanjaykumar Baldawa

Saveetha Dental College, SIMATS University

研究点 (1)

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