ORL CancerRadioT HBDNCT05494970
Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment.
An observational study of ORL Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ORL Cancer
- What is being tested?
- Accompaniment by the dental assistant.
- Type of treatment
- Pill or oral medicine
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with ORL cancer for which radiotherapy (+/- associated chemotherapy) is indicated.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31059
About this study
Official title: 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).
- Conditions
- ORL Cancer
- Being tested
- Accompaniment by the dental assistant.
- Keywords
- ORL Cancer, Oral hygiene, Radiotherapy, Written information guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ORL cancer for which radiotherapy treatment is required. | Not described Receives: Other: Accompaniment by the dental assistant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months per patient
Secondary outcomes (2)
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.
Measured: 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".
Measured: 3 months per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start13 Oct 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ORL CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494970
- Sponsor's protocol ID
- 22VADS03
- Acronym
- RadioT HBD
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT05494970
- Acronym / sponsor ID
- RadioT HBD / 22VADS03
- Conditions
- ORL Cancer
- Keywords
- ORL Cancer, Oral hygiene, Radiotherapy, Written information guide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ORL cancer for which radiotherapy treatment is required. | – | Other: Accompaniment by the dental assistant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with ORL cancer for which radiotherapy (+/- associated chemotherapy) is indicated.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients with ORL cancer for which radiotherapy treatment is required. |
Primary outcome
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.
2 secondary outcomes
Patient satisfaction with the oral hygiene information guide and the consultations performed by the dental assistant.
Time frame: 3 months per patient
The motivation of the patients towards their oral health.
Time frame: 3 months per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Results publication: PubMed 42209855Betancourt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ORL Cancer, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with improved oral hygiene between the inclusion visit and 3 months post-radiotherapy. (time frame: 3 months per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05494970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.