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

NCT05494970 | Completed

• 1 other identifier: 22VADS03
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

ORL Cancer

Keywords

ORL Cancer; Oral hygiene; Radiotherapy; Written information guide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient satisfaction with the oral hygiene information guide and the consultations performed by the dental assistant.

  3 months per patient

• The motivation of the patients towards their oral health.

  3 months per patient

Study Arms (1)

Patients with ORL cancer for which radiotherapy treatment is required.

Other: Accompaniment by the dental assistant.

Interventions

Accompaniment by the dental assistant. 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.

Patients with ORL cancer for which radiotherapy treatment is required.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with ORL cancer for which radiotherapy (+/- associated chemotherapy) is indicated.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Ligue contre le cancer, France: collaborator

Study Sites (1)

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31059, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: October 13, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

FR (1)