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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04386460
Other study ID # 20odontocovid-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 11, 2020
Est. completion date May 11, 2021

Study information

Verified date May 2020
Source Centre Hospitalier Universitaire de Nice
Contact Isabelle precheur, PUPH
Phone 33492035547
Email precheur.i@chu-nice.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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:


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 11, 2021
Est. primary completion date June 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
France University Nice Hospital Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index Body Mass Index evolution from baseline 1 Month
Primary Body Mass Index Body Mass Index evolution from baseline 3 Months
Secondary Weight changes during confinement Usual weight at baseline vs weight before confinement (gk) 8 weeks
Secondary prescription of nutritional supplements and observance number and type of nutritional supplements from baseline 3 months
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