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

Squamous Cell Carcinoma of Head and Neck Clinical Trial

— OPPIDOM  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801472
• Other study ID #: 2020-013
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: August 2022
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Valérie SARTORI
• Phone: 368767223
• Email: v.sartori[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Oral Cavity Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	Hôpitaux Universitaires de Strasbourg

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected	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)	At baseline
Secondary	Acute toxicity evaluation	according to CTCAE v5.0 criteria	every weeks during radiotherapy
Secondary	Retarded toxicity evaluation	according to CTCAE v5.0 criteria	3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Secondary	Quality of life assessed by the EORTC QLQ-C30 questionnaire	Score based on 30 items from EORTC QLQ-C30 questionnaire	At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Secondary	Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module	Score based on 35 items from EORTC QLQ-H&N35 questionnaire	At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Secondary	Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire	Score based on 14 items from OHIP-14 questionnaire	At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy
Secondary	Implant survival rate	Number of implant failure (Albrektsson modified criteria)	at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy