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Nutrition PoorNCT04386460

Covid-19 and Prevention of Malnutrition After Confinement by Dentists

An observational study of Nutrition Poor and Infection Viral, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nutrition Poor, Infection Viral, Oral Disease
How many people
17 participants
Where
1 siteFrance
Study dates
11 May 2020to 11 May 2021
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 in University hospital dental clinic

Who may be able to join

  • All subjects answering "yes" to one of these two questions: 1) "Do you eat less?" and/or 2) "Have you lost weight?"

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

France1 site
  • University Nice Hospital

    Nice, 06000

Other trials in France

About this study

Official title: Covid-19 and Prevention of Malnutrition After Confinement by Dentists: Prospective Study Among 100 Adults Received in Dental Consultation at Nice University Hospital and Sent to Their Physician for Assessment and Nutritional Care

Background. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:

Read the detailed description

Background. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:

  1. because of confinement (loneliness, anorexia, difficulty shopping) and 2) because of the untreated dental problem (oral pain or untreated edentulism). Main objective. To investigate whether dentists' recommendation to consult a physician is efficient to prevent or to treat malnutrition. Secondary objective. Conduct a medico-economic study to assess the health savings generated by the prevention of malnutrition by dentists. Type of study and population studied. Prospective cohort study including 100 adults received in hospital dental consultation, malnourished or at risk of malnutrition. Inclusion criteria. All subjects answering "yes" to one of these two questions: 1) "Do you eat less?" and/or 2) "Have you lost weight?" Exclusion criteria. None. Study design and evaluation criteria. At baseline, for all subjects included, the dentist will check the weight (kg, weighed), the usual weight (kg, question), height (m, question or from ID card), masticatory ability (score 0%-100%) and oral pain (score 0-10). Then the dentist will give the patient a note advising him to consult his doctor for assessment and management of malnutrition. The dentist will call the patient 1 month (M1) and 3 months (M3) after baseline, to ask him for his weight (kg), if he consulted his doctor (yes/no) and received nutritional supplements (if yes, what prescription). Main evaluation criterion. Body Mass Index (BMI kg/m²) evolution from baseline to M1 and M3. Secondary evaluation criteria. Weight changes during confinement, medical consultation, prescription of nutritional supplements and observance. Individual duration of the study. Three months. Total duration of the study. One year. Expected fallout. To improve the nutritional status of malnourished participants, following confinement. To anticipate malnutrition in exposed populations in the case of a second viral pandemic and confinement. Educate dentists on the importance of screening and managing malnutrition in at-risk patients.
Medical subject headings
Malnutrition, Virus Diseases, Mouth Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index

    Body Mass Index evolution from baseline

    Measured: 1 Month

  2. Body Mass Index

    Body Mass Index evolution from baseline

    Measured: 3 Months

Secondary outcomes (2)
  1. Weight changes during confinement

    Usual weight at baseline vs weight before confinement (gk)

    Measured: 8 weeks

  2. prescription of nutritional supplements and observance

    number and type of nutritional supplements from baseline

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start11 May 2020
  3. Primary completion5 Jun 2020
  4. Study completion11 May 2021

Resources

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
Cohort
Time perspective
Prospective
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386460
Sponsor's protocol ID
20odontocovid-02
Status last verified
May 2020
First submitted
12 May 2020
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Nutrition Poor and Infection Viral, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 1 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 17 Feb 2025. 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?

Body Mass Index (time frame: 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Feb 2025.

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