Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT04632004
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2020-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D006209', 'term': 'Halitosis'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within the survey study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-perceived dry mouth', 'timeFrame': 'During the 1 day of questionnaire survey', 'description': 'Questionnaire items based on the shortened Xerostomia Inventory'}, {'measure': 'Self-perceived halitosis', 'timeFrame': 'During the 1 day of questionnaire survey', 'description': 'Questionnaire items'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Mouth', 'Halitosis']}, 'referencesModule': {'references': [{'pmid': '32824564', 'type': 'BACKGROUND', 'citation': 'Farronato M, Boccalari E, Del Rosso E, Lanteri V, Mulder R, Maspero C. A Scoping Review of Respirator Literature and a Survey among Dental Professionals. Int J Environ Res Public Health. 2020 Aug 17;17(16):5968. doi: 10.3390/ijerph17165968.'}, {'pmid': '23768438', 'type': 'BACKGROUND', 'citation': 'Rebmann T, Carrico R, Wang J. Physiologic and other effects and compliance with long-term respirator use among medical intensive care unit nurses. Am J Infect Control. 2013 Dec;41(12):1218-23. doi: 10.1016/j.ajic.2013.02.017. Epub 2013 Jun 12.'}, {'pmid': '22168256', 'type': 'BACKGROUND', 'citation': 'Shenal BV, Radonovich LJ Jr, Cheng J, Hodgson M, Bender BS. Discomfort and exertion associated with prolonged wear of respiratory protection in a health care setting. J Occup Environ Hyg. 2012;9(1):59-64. doi: 10.1080/15459624.2012.635133.'}, {'pmid': '34501768', 'type': 'RESULT', 'citation': 'Kanzow P, Dylla V, Mahler AM, Hrasky V, Rodig T, Barre F, Scheithauer S, Wiegand A. COVID-19 Pandemic: Effect of Different Face Masks on Self-Perceived Dry Mouth and Halitosis. Int J Environ Res Public Health. 2021 Aug 31;18(17):9180. doi: 10.3390/ijerph18179180.'}]}, 'descriptionModule': {'briefSummary': 'During the current COVID-19 pandemic, the use of face masks is recommended / mandatory to prevent infection. Patients and students have reported to experience limitations in their oral health-related quality of life, especially with regard to the occurrence of dry mouth and halitosis, while wearing face masks.\n\nScientific studies regarding the effects of face masks have so far focused exclusively on medical staff. Studies among the general population are not yet available, but are of interest as dry mouth is a risk factor for dental diseases (e.g., caries, erosion).\n\nTherefore, the present study aims at performing a questionnaire survey regarding self-perceived dry mouth and halitosis and the use of face masks (type, wearing time).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, visitors, and staff members of the University Medical Center Goettingen\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT04632004', 'briefTitle': 'Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'officialTitle': 'Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health', 'orgStudyIdInfo': {'id': 'FaceMasks-OralHealth'}, 'secondaryIdInfos': [{'id': '28/10/20', 'type': 'OTHER', 'domain': 'Local Ethics Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Questionnaire survey', 'description': 'Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within our survey study. Study participation has no effect on any medical treatment.', 'interventionNames': ['Other: Invitation to participate']}], 'interventions': [{'name': 'Invitation to participate', 'type': 'OTHER', 'description': 'Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within our survey study. Study participation has no effect on any medical treatment.', 'armGroupLabels': ['Questionnaire survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Göttingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Dental Practitioner', 'investigatorFullName': 'Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic.', 'investigatorAffiliation': 'University Medical Center Goettingen'}}}}