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ORFCovid: Oral Health in Covid-19 Survivors

Sponsor
University of Belgrade (Other)
Overall Status
Recruiting
CT.gov ID
NCT05205694
Collaborator
(none)
210
Enrollment
1
Location
21.3
Anticipated Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aims are to assess periodontal health and salivary stress/ immunity responses in COVID-19 survivors

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    210 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Biomarkers of Oral Health in Covid-19 Survivors
    Actual Study Start Date :
    Sep 20, 2021
    Anticipated Primary Completion Date :
    May 31, 2022
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Late COVID-19 and PERIO

    Participants in the late convalescent stage of COVID-19 with diagnosed periodontitis
    PERIO non COVID-19

    Participants with diagnosed periodontitis and no history of COVID-19
    Late COVID-19 non PERIO

    Participants in the late convalescent stage of COVID-19 without periodontitis
    Non PERIO non COVID-19

    Participants with no history of COVID-19 and without periodontitis

    Outcome Measures

    Primary Outcome Measures

    1. Periodontal disease stage and COVID 19 [one to six months after COVID-19]

      Correlation periodontitis and COVID 19 infection

    Secondary Outcome Measures

    1. Oral frailty [one to six months after COVID-19]

      Oral frailty assessment in Covid 19 and Perio affected patients

    2. psychological stress [one to six months after COVID-19]

      Assessment of psychological stress

    3. salivary stress/immunity mediators [one to six months after COVID-19]

      Association of salivary stress/immunity mediators levels with perio disease in COVID 19 patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • history of periodontal treatment in previous six months, acute oral infection, presence of systemic disease(s), pregnancy, lactation, smoking ≥ 10 cigarettes per day

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Dental Medicine University of Belgrade Belgrade Serbia 11000

    Sponsors and Collaborators

    • University of Belgrade

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jelena Roganović, Associate Professor, University of Belgrade
    ClinicalTrials.gov Identifier:
    NCT05205694
    Other Study ID Numbers:
    • 36/10
    First Posted:
    Jan 25, 2022
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Periodontitis

    Study Results

    No Results Posted as of Jan 25, 2022