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

Institut de cancérologie Strasbourg Europe

Status: Terminated

Conditions: Squamous Cell Carcinoma of Head and Neck; Oral Cavity Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma

Treatments: Other: Optimisation of dental implant sites protection from irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT04801472

2020-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Patients with oral cavity or oropharyngeal squamous cell carcinoma

Other group

Treatment:

Other: Optimisation of dental implant sites protection from irradiation