Clinical trial NCT04801472: Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Oropharyngeal Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Keywords: Radiotherapy
Head and Neck cancer
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
Collaborators: name: Hôpitaux Universitaires de Strasbourg
First posted: 2021-03-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected
timeFrame: At baseline
Secondary outcomes:
measure: Acute toxicity evaluation
timeFrame: every weeks during radiotherapy
measure: Retarded toxicity evaluation
timeFrame: 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
measure: Quality of life assessed by the EORTC QLQ-C30 questionnaire
timeFrame: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
measure: Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module
timeFrame: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
measure: Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire
timeFrame: At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
measure: Implant survival rate
timeFrame: at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References: