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

August 2, 2022 updated by: Institut de cancérologie Strasbourg Europe
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67033
        • Recruiting
        • Institut de cancerologie Strasbourg Europe
        • Principal Investigator:
          • Georges NOEL, MD PhD
        • Sub-Investigator:
          • Fabien BORNERT, Dental Surgeon
        • Sub-Investigator:
          • Youssef BRAHIMI, MD
        • Sub-Investigator:
          • Minh-Nhat NGUYEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of optimal scanner allowing to obtain the greater number of patients with every designated implant sites that are protected
Time Frame: 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)
At baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de cancérologie Strasbourg Europe

Collaborators

Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2021

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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