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 (Other)

Overall Status

Recruiting

CT.gov ID

NCT04801472

Collaborator

Hôpitaux Universitaires de Strasbourg (Other)

Enrollment

Location

Arm

29.8

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of Head and Neck Oropharyngeal Squamous Cell Carcinoma Oral Cavity Squamous Cell Carcinoma	Other: Optimisation of dental implant sites protection from irradiation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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)

Actual Study Start Date :

May 7, 2021

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with oral cavity or oropharyngeal squamous cell carcinoma	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

Arm

Intervention/Treatment

Other: Patients with oral cavity or oropharyngeal squamous cell carcinoma

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

Outcome Measures

Primary Outcome Measures

Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected [At baseline]
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)

Secondary Outcome Measures

Acute toxicity evaluation [every weeks during radiotherapy]
according to CTCAE v5.0 criteria
Retarded toxicity evaluation [3 months, 6 months, 12 months, 18 months after the end of radiotherapy]
according to CTCAE v5.0 criteria
Quality of life assessed by the 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]
Score based on 30 items from EORTC QLQ-C30 questionnaire
Quality of life for patient with Head and Neck Cancer assessed by the EORTC QLQ-H&N35 supplementary questionnaire module [At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy]
Score based on 35 items from EORTC QLQ-H&N35 questionnaire
Oral health-related impact on patients quality of life assessed by the OHIP-14 questionnaire [At baseline, every weeks during radiotherapy and at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy]
Score based on 14 items from OHIP-14 questionnaire
Implant survival rate [at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy]
Number of implant failure (Albrektsson modified criteria)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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