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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
Optimal treatment plan validation after two dosimetric computer-tomography scans (with or without radiological guide) and visualisation of virtual dental implants on scanner images. Evaluation of toxicity, quality of life and dental implant survival rate
Institut de cancérologie Strasbourg Europe
Strasbourg, France
Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected
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)
Time frame: At baseline
Acute toxicity evaluation
according to CTCAE v5.0 criteria
Time frame: every weeks during radiotherapy
Retarded toxicity evaluation
according to CTCAE v5.0 criteria
Time frame: 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Quality of life assessed by the EORTC QLQ-C30 questionnaire
Score based on 30 items from EORTC QLQ-C30 questionnaire
Time frame: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module
Score based on 35 items from EORTC QLQ-H\&N35 questionnaire
Time frame: 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
Score based on 14 items from OHIP-14 questionnaire
Time frame: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Implant survival rate
Number of implant failure (Albrektsson modified criteria)
Time frame: at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
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