CClinicalTrials.gg
CompletedNCT05494970RadioT HBDUpdated Sep 18, 2026

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

An observational study in ORL Cancer, sponsored by Institut Claudius Regaud. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Institut Claudius Regaud · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
44
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • ORL Cancer

Keywords

  • ORL Cancer
  • Oral hygiene
  • Radiotherapy
  • Written information guide
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In context

Lead sponsor

Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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).
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with ORL cancer for which radiotherapy treatment is required.

    Other: Accompaniment by the dental assistant.

Interventions

  • OtherAccompaniment 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.

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What researchers measure

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.

    Time frame: 3 months per patient

Secondary outcomes

  1. 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.

    Time frame: 3 months per patient

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

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

    Time frame: 3 months per patient

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Study locations

1 site
  • Institut Universitaire du Cancer Toulouse - Oncopole
    Toulouse, 31059, France
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References and documents

Publications

  • Betancourt S, Cavillon A, Teulieres MC, Cabarrou B, Epstein JB, Vigarios E, Maret D. Educational Interventions in Oral Hygiene for Patients Undergoing Head and Neck Cancer Radiotherapy: A Feasibility Study. J Cancer Educ. 2026 May 28. doi: 10.1007/s13187-026-02849-6. Online ahead of print. PubMed 42209855 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05494970
Lead sponsor
Institut Claudius Regaud
Collaborators
Ligue contre le cancer, France
Responsible party
Sponsor
First posted
Aug 10, 2022
Start date
Oct 13, 2022
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Last update
Sep 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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