TerminatedNot Applicable

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

Stopped: organisationnal reason

France8 participantsStarted 2021-05-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected

Timeframe: At baseline

Trial details

NCT IDNCT04801472

SponsorInstitut de cancérologie Strasbourg Europe

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-17