Trials / Terminated
TerminatedNCT04801472
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
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Institut de cancérologie Strasbourg Europe · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Squamous Cell Carcinoma of Head and Neck
- Oropharyngeal Squamous Cell Carcinoma
- Oral Cavity Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Optimisation of dental implant sites protection from irradiation | 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 |
Timeline
- Start date
- 2021-05-07
- Primary completion
- 2025-06-17
- Completion
- 2025-06-17
- First posted
- 2021-03-17
- Last updated
- 2026-01-05
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04801472. Inclusion in this directory is not an endorsement.