NCT04801472

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2025

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

March 11, 2021

Last Update Submit

December 30, 2025

Conditions

Oral Cavity Squamous Cell CarcinomaSquamous Cell Carcinoma of Head and NeckOropharyngeal Squamous Cell Carcinoma

Keywords

RadiotherapyHead and Neck cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Acute toxicity evaluation

    every weeks during radiotherapy

  • Retarded toxicity evaluation

    3 months, 6 months, 12 months, 18 months after the end of radiotherapy

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Patients with oral cavity or oropharyngeal squamous cell carcinoma

OTHER
Other: Optimisation of dental implant sites protection from irradiation

Interventions

Optimisation of dental implant sites protection from irradiationOTHER

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

Patients with oral cavity or oropharyngeal squamous cell carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of head and neck radiotherapy
  • Partial mandibulectomy
  • Retarded wound healing or trismus impairing radiological guide preparation
  • Patient refusing the study
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by Site

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 17, 2021

Study Start

May 7, 2021

Primary Completion

June 17, 2025

Study Completion

June 17, 2025

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

FR(1)