Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)

Conditions
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Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma

Intervention / Treatment
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* Other: Optimisation of dental implant sites protection from irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: History of head and neck radiotherapy Partial mandibulectomy Retarded wound healing or trismus impairing radiological guide preparation Patient refusing the study Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with oral cavity or oropharyngeal squamous cell carcinoma<br> | Other: Optimisation of dental implant sites protection from irradiation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity evaluation | according to CTCAE v5.0 criteria | every weeks during radiotherapy | 
| Retarded toxicity evaluation | according to CTCAE v5.0 criteria | 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 | 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 | 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 | 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) | at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Head and Neck cancer