Evaluation of The Radioprotective Effect of 3D-Printed Intraoral Stents in Children With Brain Cancer.

N/ANot Yet RecruitingNCT07715357

Ain Shams University72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Medulloblastoma Tumor

3D printed intraoral stents.DEVICE

Custom-designed, biocompatible 3D-printed intraoral stent tailored to the patient's oral anatomy. The device will be manufactured using intraoral scanning data , then will be printed using medical-grade resin. During each radiotherapy session for medulloblastoma, the patient will wear the stent inside the mouth to physically displace and shield healthy oral mucosa away from the high-dose radiation target volume, minimizing radiation-induced mucositis."

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who will receive 5-7 weeks of definitive radiotherapy for treatment of a diagnosed medulloblastoma tumor. 2. Age less than 18 years old. 3. No Evidence of oral mucositis at baseline (WHO grade 0) Exclusion Criteria: 1. Patients with prior exposure to head and neck radiotherapy. 2. Patients who are unable to wear oral stent. 3. Patients with known allergies or hypersensitivity to dental resin materials.

Outcomes

Primary Outcomes

Assessment of the oral mucositis severity in children below 18 years old diagnosed with medulloblastoma tumor.

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).

Time frame: Assessments will be carried out weekly during radiotherapy and 3 months after radiotherapy.

Secondary Outcomes

Priodontal health status .

Will be assessed using (Löe \& Silness index),Scores range from 0 to 3, where 0 = no plaque and 3 = abundant plaque accumulation. Higher scores indicate poorer oral hygiene (worse outcome).

Time frame: Assessment will be carried out weekly during radiotherapy and after 3,6 and 12 months.

Radiation-induced caries

Will be assessed using DMFT index. Scores range from 0 to the maximum number of teeth assessed (e.g., up to 28 permanent teeth excluding third molars, depending on the dentition). Higher scores indicate greater dental caries experience (worse outcome).

Time frame: Assessment will be before radiotherapy and 3,6,12 months after radiotherapy.