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

Not Applicable

• Conditions: Squamous Cell Carcinoma of Head and Neck; Oral Cavity Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma
• Interventions: Other: Optimisation of dental implant sites protection from irradiation

• Registration Number: NCT04801472
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

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 Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Study Start: 2021-05-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with oral cavity or oropharyngeal squamous cell carcinoma	Optimisation of dental implant sites protection from irradiation	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Retarded toxicity evaluation	3 months, 6 months, 12 months, 18 months after the end of radiotherapy	according to CTCAE v5.0 criteria
Acute toxicity evaluation	every weeks during 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
Implant survival rate	at 3 months, 6 months, 12 months, 18 months after the end of radiotherapy	Number of implant failure (Albrektsson modified criteria)

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France