- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386460
Covid-19 and Prevention of Malnutrition After Confinement by Dentists
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Isabelle precheur, PUPH
- Phone Number: 33492035547
- Email: precheur.i@chu-nice.fr
Study Contact Backup
- Name: valerie Pouyssegur, PH
- Phone Number: 333492033270
- Email: pouyssegur.v@chu-nice.fr
Study Locations
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-
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Nice, France, 06000
- Recruiting
- University Nice Hospital
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Contact:
- Isabelle precheur, PUPH
- Phone Number: 33492035547
- Email: precheur.i@chu-nice.fr
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Principal Investigator:
- isabelle precheur
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index
Time Frame: 1 Month
|
Body Mass Index evolution from baseline
|
1 Month
|
Body Mass Index
Time Frame: 3 Months
|
Body Mass Index evolution from baseline
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight changes during confinement
Time Frame: 8 weeks
|
Usual weight at baseline vs weight before confinement (gk)
|
8 weeks
|
prescription of nutritional supplements and observance
Time Frame: 3 months
|
number and type of nutritional supplements from baseline
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20odontocovid-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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