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Completed

NCT Number: NCT05494970

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

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).

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Key information

Conditions

ORL Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 3 months per patient

    It will be evaluated by means of a satisfaction questionnaire.

  2. The motivation of the patients towards their oral health.

    Time frame: 3 months per patient

    It will be evaluated with the questionnaire "Motivation and oral hygiene behavior".

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • Ligue contre le cancer, France

Registry information

Official study title

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

Acronym: RadioT HBD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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