Neoplasms

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Squamous Cell Carcinoma of Head and Neck

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Neoplasms, Squamous Cell

Oral Squamous Cell Carcinoma

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

Optimisation of dental implant sites protection from irradiation

Valérie SARTORI

Manon VOEGELIN, PhD

Manon VOEGELIN

Georges NOEL, MD PhD

Fabien BORNERT, Dental Surgeon

Youssef BRAHIMI, MD

Minh-Nhat NGUYEN

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.

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

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)

Score based on 30 items from EORTC QLQ-C30 questionnaire

Score based on 35 items from EORTC QLQ-H\&N35 questionnaire

Score based on 14 items from OHIP-14 questionnaire

Number of implant failure (Albrektsson modified criteria)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)	NCT04801472	Squamous Cell C... Oropharyngeal S... Oral Cavity Squ...	Optimisation of...	18 Years -	Institut de cancérologie Strasbourg Europe
Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)	NCT04801472	Squamous Cell C... Oropharyngeal S... Oral Cavity Squ...	Optimisation of...	18 Years -	Institut de cancérologie Strasbourg Europe
Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)	NCT04801472	Squamous Cell C... Oropharyngeal S... Oral Cavity Squ...	Optimisation of...	18 Years -	Institut de cancérologie Strasbourg Europe
Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)	NCT04801472	Squamous Cell C... Oropharyngeal S... Oral Cavity Squ...	Optimisation of...	18 Years -	Institut de cancérologie Strasbourg Europe

Spots Global Cancer Trial Database for optimisation of dental implant sites protection from irradiation