- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05494970
Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment. (RadioT HBD)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Sabine BETANCOURT
- Phone Number: 05 31 15 60 83
- Email: betancourt.sabine@iuct-oncopole.fr
Study Locations
-
-
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Toulouse, France, 31059
- Institut Universitaire du Cancer Toulouse - Oncopole
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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