Evaluation of The Radioprotective Effect of 3D-Printed Intraoral Stents in Children With Brain Cancer: A Randomized Clinical Trial and An In-Vitro Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Assessment of the oral mucositis severity in children below 18 years old diagnosed with medulloblastoma tumor.
研究概览
简要总结
Brain cancer patients undergoing radiotherapy may experience oral complications such as oral mucositis, gingival inflammation, plaque accumulation, radiation-induced caries, and reduced oral-health-related quality of life due to scatter radiation affecting oral tissues.
Although intraoral stents are used to protect and reposition oral structures during radiotherapy, conventional stents lack standardization in material properties and thickness, leading to variable radioprotective effectiveness. Advances in 3D printing allow fabrication of customized resin intraoral stents with controlled thickness. However, there is not a lot of research in the literature about the materials that are employed as intraoral radiation stents to reduce the radiation dosage received by healthy tissue. Since these devices can lower radiation exposure to healthy tissues, the current study seeks to evaluate the degree of attenuation of therapeutic radiation with four different thicknesses for the intraoral stents and then assess the clinical effectiveness of the optimized thickness of the 3D-printed resin intraoral stent in reducing oral mucositis, periodontal health status, radiation induced caries, and in improving patient-reported outcomes in brain cancer patients undergoing radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will receive 5-7 weeks of definitive radiotherapy for treatment of a diagnosed medulloblastoma tumor.
- •Age less than 18 years old.
- •No Evidence of oral mucositis at baseline (WHO grade 0)
排除标准
- •Patients with prior exposure to head and neck radiotherapy.
- •Patients who are unable to wear oral stent.
- •Patients with known allergies or hypersensitivity to dental resin materials.
研究组 & 干预措施
Standard care control group
Patients receiving standard oral care instructions without the use of an intraoral stent (control group).
3D printed intraoral stent group
Patients will wear the 3D printed intraoral stent during radiotherapy sessions.
干预措施: 3D printed intraoral stents. (Device)
结局指标
主要结局
Assessment of the oral mucositis severity in children below 18 years old diagnosed with medulloblastoma tumor.
时间窗: Assessments will be carried out weekly during radiotherapy and 3 months after radiotherapy.
Will be assessed using WHO "World Health Organization" Oral Mucositis Scale, Scores range from 0 to 4, where 0 = no mucositis and 4 = severe mucositis preventing oral alimentation. Higher scores indicate more severe oral mucositis (worse outcome).
次要结局
- Priodontal health status .(Assessment will be carried out weekly during radiotherapy and after 3 months.)
- Radiation-induced caries(Assessment will be before radiotherapy and 3,6,12 months after radiotherapy.)
- Priodontal health status .(Assessment will be carried out weekly during radiotherapy and after 3,6 and 12 months.)