Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT04386460
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid-19 and Prevention of Malnutrition After Confinement by Dentists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': '1 Month', 'description': 'Body Mass Index evolution from baseline'}, {'measure': 'Body Mass Index', 'timeFrame': '3 Months', 'description': 'Body Mass Index evolution from baseline'}], 'secondaryOutcomes': [{'measure': 'Weight changes during confinement', 'timeFrame': '8 weeks', 'description': 'Usual weight at baseline vs weight before confinement (gk)'}, {'measure': 'prescription of nutritional supplements and observance', 'timeFrame': '3 months', 'description': 'number and type of nutritional supplements from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition Poor', 'Infection Viral', 'Oral Disease']}, 'descriptionModule': {'briefSummary': '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:', 'detailedDescription': '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:\n\n1\\) 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient in University hospital dental clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects answering "yes" to one of these two questions: 1) "Do you eat less?" and/or 2) "Have you lost weight?"\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04386460', 'briefTitle': 'Covid-19 and Prevention of Malnutrition After Confinement by Dentists', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '20odontocovid-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'University Nice Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}