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

Completed

• Conditions: ORL Cancer
• Interventions: Other: Accompaniment by the dental assistant.

• Registration Number: NCT05494970
• Lead Sponsor: Institut Claudius Regaud

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2022-10-13
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ORL cancer for which radiotherapy treatment is required.	Accompaniment by the dental assistant.	-

Primary Outcome Measures

Name	Time	Method
Rate of patients with improved oral hygiene between the inclusion visit and 3 months post-radiotherapy.	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with the oral hygiene information guide and the consultations performed by the dental assistant.	3 months per patient	It will be evaluated by means of a satisfaction questionnaire.
The motivation of the patients towards their oral health.	3 months per patient	It will be evaluated with the questionnaire "Motivation and oral hygiene behavior".

Trial Locations

Locations (1)

Institut Universitaire du Cancer Toulouse - Oncopole; 🇫🇷 Toulouse, France