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

NCT ID: NCT05494970

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-13

Study Completion Date

2024-01-30

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 post-radiotherapy (follow-up for up to 12 months post-inclusion).

Detailed Description

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Conditions

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ORL Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with ORL cancer for which radiotherapy treatment is required.

Accompaniment by the dental assistant.

Intervention Type OTHER

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.

Interventions

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Accompaniment by the dental assistant.

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years at study entry.
2. Patient with ORL cancer requiring radiotherapy (+/- associated chemotherapy).
3. Patient with a plaque index \> or = 30%.
4. Patient affiliated to a social security system in France.
5. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria

1. Pregnant or lactating women.
2. 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.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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22VADS03

Identifier Type: -

Identifier Source: org_study_id

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