Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment. (RadioT HBD)
September 15, 2026 updated by: Institut Claudius Regaud
Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment: a Feasibility Study.
Feasibility, prospective, monocentric study aiming to evaluate the interest of a written information guide, given and explained by the dental assistant, on the improvement of the oral hygiene of patients with ORL cancer at 3 months post-radiotherapy.
The study will be conducted on a population of 44 patients with ORL cancer requiring radiation treatment.
Each patient will be followed during 3 months post-radiotherapy (follow-up for up to 12 months post-inclusion).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
44
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
-
-
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Toulouse, France, 31059
- Institut Universitaire du Cancer Toulouse - Oncopole
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-
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
Sampling Method
Probability Sample
Study Population
Patient with ORL cancer for which radiotherapy (+/- associated chemotherapy) is indicated.
Description
Inclusion Criteria:
- Age ≥ 18 years at study entry.
- Patient with ORL cancer requiring radiotherapy (+/- associated chemotherapy).
- Patient with a plaque index > or = 30%.
- Patient affiliated to a social security system in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
Exclusion Criteria:
- Pregnant or lactating women.
- Any psychological, familial, geographic or sociological condition that does not allow for compliance with the medical follow-up and/or procedures outlined in the study protocol.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with ORL cancer for which radiotherapy treatment is required.
|
Inclusion visit (before radiotherapy treatment):
End of study visit (three months post-radiotherapy): • The "Motivation and oral hygiene behavior" and the satisfaction questionnaires will be completed by the patient. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of patients with improved oral hygiene between the inclusion visit and 3 months post-radiotherapy.
Time Frame: 3 months per patient
|
Improvement is defined as a gross decrease of at least 30% in the plaque index between the inclusion visit and 3 months post-radiotherapy.
The plaque index will be evaluated using the O'Leary method.
|
3 months per patient
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction with the oral hygiene information guide and the consultations performed by the dental assistant.
Time Frame: 3 months per patient
|
It will be evaluated by means of a satisfaction questionnaire.
|
3 months per patient
|
|
The motivation of the patients towards their oral health.
Time Frame: 3 months per patient
|
It will be evaluated with the questionnaire "Motivation and oral hygiene behavior".
|
3 months per patient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 13, 2022
Primary Completion (Actual)
January 30, 2024
Study Completion (Actual)
January 30, 2024
Study Registration Dates
First Submitted
August 8, 2022
First Submitted That Met QC Criteria
August 8, 2022
First Posted (Actual)
August 10, 2022
Study Record Updates
Last Update Posted (Actual)
September 18, 2026
Last Update Submitted That Met QC Criteria
September 15, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 22VADS03
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.