Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment.

Study Overview
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Brief Summary
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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.

Official Title
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Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment: a Feasibility Study.

Conditions
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ORL Cancer

Intervention / Treatment
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* Other: Accompaniment by the dental assistant.


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with ORL cancer for which radiotherapy treatment is required.<br> | Other: Accompaniment by the dental assistant.<br>* Inclusion visit (before radiotherapy treatment): oral hygiene education (prevention of complications related to radiotherapy) will be provided by the dental assistant. a written information guide on oral hygiene will be given to the patient. the questionnaire entitled Motivation and oral hygiene behavior will be completed by the patient. End of study visit (three months post-radiotherapy): • The Motivation and oral hygiene behavior and the satisfaction questionnaires will be completed by the patient.<br>|

What is the study measuring?
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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. | 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. | It will be evaluated by means of a satisfaction questionnaire. | 3 months per patient | 
| The motivation of the patients towards their oral health. | It will be evaluated with the questionnaire Motivation and oral hygiene behavior. | 3 months per patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ORL Cancer, Oral hygiene, Radiotherapy, Written information guide