Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected
研究概览
简要总结
This is a monocentric, non-randomized, prospective, in silico feasibility study conducted by Strasbourg Europe Cancerology Institute. The purpose of this study is to evaluate the optimisation of potential dental implant sites protection, without degrading tumor volume coverage, through designation of potential dental implant sites before volume delineation and dosimetry calculations in patients with oropharyngeal or oral cavity squamous cell carcinoma treated by radiotherapy.
详细描述
35 patients will be included in this study and will benefit from a dental consultation for dental rehabilitation plan elaboration and radiological guide confection. Two dosimetric computer-tomography scans, with or without radiological guide, will be conducted. Virtual dental implants will be visualised by the dental surgeon on scanner images (with or without radiologic guide). After volume delineation and dosimetry calculations, the optimal treatment plan will be validated. Patients will be followed throughout radiotherapy and during 18 months following the end of radiotherapy for evaluation of toxicity, quality of life and dental implant survival rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 18 years old
- •Performance Status 0 to 2
- •Histologically-confirmed diagnosis of : infiltrating squamous cell carcinoma of the oral cavity or oropharynx
- •Indication for an exclusive radiotherapy or post-surgery radiotherapy, with or without chemotherapy
- •Indication for a radiotherapy of lymph node areas
- •Partial or complete toothlessness requiring rehabilitation
- •Signed informed consent from the patient
排除标准
- •History of head and neck radiotherapy
- •Partial mandibulectomy
- •Retarded wound healing or trismus impairing radiological guide preparation
- •Patient refusing the study
- •Pregnant women
结局指标
主要结局
Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected
时间窗: At baseline
Condition of dental implant sites protection (i.e. with minimal implantation risk, Dmax \< 40 Gy), without degrading the coverage of planned targeted volume (≥ 95% of volume receiving 95 % of prescribed dose)
次要结局
- Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module(At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy)
- Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire(At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy)
- Retarded toxicity evaluation(3 months, 6 months, 12 months, 18 months after the end of radiotherapy)
- Acute toxicity evaluation(every weeks during radiotherapy)
- Quality of life assessed by the EORTC QLQ-C30 questionnaire(At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy)
- Implant survival rate(at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy)