Viewing Study NCT04801472



Ignite Creation Date: 2024-05-06 @ 3:55 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04801472
Status: UNKNOWN
Last Update Posted: 2022-08-04
First Post: 2021-03-11

Brief 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
Sponsor: Institut de cancérologie Strasbourg Europe
Organization: Institut de cancérologie Strasbourg Europe

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2022-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: OPPIDOM
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None