NCT04386460

Brief 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:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2021

Completed
Last Updated

February 17, 2025

Status Verified

May 1, 2020

Enrollment Period

25 days

First QC Date

May 12, 2020

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Body Mass Index

    Body Mass Index evolution from baseline

    1 Month

  • Body Mass Index

    Body Mass Index evolution from baseline

    3 Months

Secondary Outcomes (2)

  • Weight changes during confinement

    8 weeks

  • prescription of nutritional supplements and observance

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient in University hospital dental clinic

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Nice Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

MalnutritionVirus DiseasesMouth Diseases

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesInfectionsStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 13, 2020

Study Start

May 11, 2020

Primary Completion

June 5, 2020

Study Completion

May 11, 2021

Last Updated

February 17, 2025

Record last verified: 2020-05

Locations