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: Completed
• Conditions: ORL Cancer
• Intervention / Treatment: Other: Accompaniment by the dental assistant.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer Toulouse - Oncopole

Participation Criteria

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:

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with ORL cancer for which radiotherapy treatment is required.

Other: 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.

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.	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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Collaborators: Ligue contre le cancer, France

Study record dates

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): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Oral hygiene; ORL Cancer; Written information guide
• 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