Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT05205694
Status:
UNKNOWN
Last Update Posted:
2022-01-25
First Post:
2022-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Health in Covid-19 Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-22', 'studyFirstSubmitDate': '2022-01-22', 'studyFirstSubmitQcDate': '2022-01-22', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontal disease stage and COVID 19', 'timeFrame': 'one to six months after COVID-19', 'description': 'Correlation periodontitis and COVID 19 infection'}], 'secondaryOutcomes': [{'measure': 'Oral frailty', 'timeFrame': 'one to six months after COVID-19', 'description': 'Oral frailty assessment in Covid 19 and Perio affected patients'}, {'measure': 'psychological stress', 'timeFrame': 'one to six months after COVID-19', 'description': 'Assessment of psychological stress'}, {'measure': 'salivary stress/immunity mediators', 'timeFrame': 'one to six months after COVID-19', 'description': 'Association of salivary stress/immunity mediators levels with perio disease in COVID 19 patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Periodontitis']}, 'descriptionModule': {'briefSummary': 'Aims are to assess periodontal health and salivary stress/ immunity responses in COVID-19 survivors', 'detailedDescription': 'There are lack of data concerning oral health in COVID-19 survivors, nevertheless, many middle-aged patients with oral symptoms of Post-acute COVID-19 report xerostomia and taste impairment and suffer from oral hypofunction, thus may be susceptible to periodontitis and oral frailty. Post-acute or long COVID-19 is/would be the health hallmark of post-COVID-19 era, manifested as a multiplicity of clinical problems and requiring conceptual framework aiming at multidisciplinary health preserving activities. There are various factors which may affect oral and periodontal health in post-COVID-19 era, such as disruption of dental professional care due to the fear of infection, virus-induced disturbance of oral homeostasis and, as a common denominator- COVID-19-induced psychological stress. Expected results would not just offer epidemiological data but also, mechanistic background for defining risks and modified measures aiming to preserve oral health in post-COVID-19 era.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Groups I and III will include COVID-19 survivors in late convalescent stage (one to six months post onset of symptoms accompanied by SARS-CoV-2- positive nasopharyngeal swab result) who had non-severe COVID-19 (no or mild pneumonia - less than 50 percent lung involvement on imaging within 24 to 48 hours, absence of dyspnea and hypoxia). Groups II and IV will include participants who report to had no symptoms of COVID-19 and had no SARS-CoV-2- positive nasopharyngeal swab result', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-reported good general health, ≥ 14 erupted teeth excluding third molars. For periodontally healthy: Bleeding on probing score ≤10%, without attachment loss and radiographic bone loss and probing depth ≤ 3 mm in every site (Trombelli L et al., 2018). For periodontitis patients: periodontitis in stages II-IV.\n\nExclusion Criteria:\n\n* history of periodontal treatment in previous six months, acute oral infection, presence of systemic disease(s), pregnancy, lactation, smoking ≥ 10 cigarettes per day'}, 'identificationModule': {'nctId': 'NCT05205694', 'acronym': 'ORFCovid', 'briefTitle': 'Oral Health in Covid-19 Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Biomarkers of Oral Health in Covid-19 Survivors', 'orgStudyIdInfo': {'id': '36/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Late COVID-19 and PERIO', 'description': 'Participants in the late convalescent stage of COVID-19 with diagnosed periodontitis'}, {'label': 'PERIO non COVID-19', 'description': 'Participants with diagnosed periodontitis and no history of COVID-19'}, {'label': 'Late COVID-19 non PERIO', 'description': 'Participants in the late convalescent stage of COVID-19 without periodontitis'}, {'label': 'Non PERIO non COVID-19', 'description': 'Participants with no history of COVID-19 and without periodontitis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Jelena Roganović, Professor', 'role': 'CONTACT'}], 'facility': 'School of Dental Medicine University of Belgrade', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'centralContacts': [{'name': 'Jelena Roganović, Professor', 'role': 'CONTACT', 'email': 'jelena.roganovic@stomf.bg.ac.rs', 'phone': '+381641976330'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jelena Roganović', 'investigatorAffiliation': 'University of Belgrade'}}}}