Comparison Between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy Tissues, Salivary PH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Dosimetric analysis
研究概览
简要总结
The goal of this clinical trial is to compare between the Effect of Using Conventional and Digital Oral Positional Radiation Stent on Healthy tissues, salivary PH. The main question it aims to answer are: Does the difference in manufacturing method affect on Healthy tissues, salivary PH.
Participants will use radiation positioning stent during radiotherapy sessions Two groups will be compared
- Group A: OPRS was constructed according to the conventional technique.
- Group B: OPRS was constructed digitally using CAD /CAM technology. to evaluate Dosimetric analysis to quantify the radiation dose in OARs, PH of saliva measurement and Mucositis assessment.
详细描述
This study will be a clinically prospective study that will include 16 patients with head and neck cancer. This study will be carried out at the Clinical Prosthodontics Department & Clinical Oncology Department of Tanta University.
Informed consent will be obtained from all patients with maintenance of their privacy prior to inclusion in the study according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
Patient's evaluation:
All patients will be subjected to the following protocol:
Oral examination: Clinical dental evaluation, intraoral photography and mouth opening measurements
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Limit of age was between 20 -40 years old.
- •Inter-arch distance ≥ 1.5 cm
- •Good oral hygiene.
排除标准
- •Patients with conditions that limited the construction of the stent (e.g. gross tumor block most of the oral cavity, sever limited mouth opening)
- •Patients with recurrent cancerous lesions.
- •Edentulous patients.
- •Previously radiotherapy for head and neck
结局指标
主要结局
Dosimetric analysis
时间窗: 1 week
The teeth away from the target site, both parotid glands and the maxilla, and OARs were defined and contoured in CT pre-irradiation planning using ECLIPSE software to each patient with the stent and without it and the mean corresponding dose of each structure was acquired using a dose volume histogram (DVH).
PH of saliva measurement:
时间窗: 4 weeks
Salivary PH was measured by digital PH meter before beginning of RT and the measurement was continued weekly throughout the treatment period till its end.
Mucositis assessment:
时间窗: 4 weeks
The severity of mucositis was assessed weekly from the beginning of RT to the end of the treatment at the RT department. The grading was scored in accordance with the Mucositis grading of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), grading scores from 0-4 which 0 means better (None) and 4 means worse (Necrosis or deep ulceration; may include bleeding not induced by minor trauma or abrasion)
次要结局
未报告次要终点
研究者
Samar Hesham Maklad
Teaching assistant at faculty of dentistry
Tanta University