NCT04791436

Brief Summary

This cohort study aims to investigate the long-standing chemosensory disorders and oral manifestation after recovery of the COVID-19 illness. A correlation between the long-standing symptoms and the COVID-19 severity grade will be very important to understand and clarify the aetiology of these symptoms.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

March 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

3.8 years

First QC Date

March 7, 2021

Last Update Submit

May 9, 2024

Conditions

Keywords

COVID-19Oral ManifestationsOlfactory Manifestations

Outcome Measures

Primary Outcomes (4)

  • Periodontal health

    Community Periodontal Index (CPI) of the World Health Organization (WHO) will be used to assess periodontal health (continuous variable)

    At least 3 months after recovery of COVID-19

  • Oral mucocutaneous lesions

    An intraoral examination will be carried out to assess the presence of any mucocutaneous lesions (dichotomous variable)

    At least 3 months after recovery of COVID-19

  • Gustatory function

    Burghart Sniffin' Sticks "Screening 12 Test" will be used to assess gustatory function (continuous variable)

    At least 3 months after recovery of COVID-19

  • Olfactory function

    Burghart Sniffin' Sticks "Screening 12 Test" will be used to assess olfactory function (continuous variable)

    At least 3 months after recovery of COVID-19

Study Arms (3)

Mild Illness

Recovered COVID-19 patients who experienced a mild clinical course

Diagnostic Test: Gustatory and olfactory function testDiagnostic Test: Molecular assessment of saliva

Moderate Illness

Recovered COVID-19 patients who experienced a moderate clinical course

Diagnostic Test: Gustatory and olfactory function testDiagnostic Test: Molecular assessment of saliva

Severe Illness

Recovered COVID-19 patients who experienced a severe clinical course

Diagnostic Test: Gustatory and olfactory function testDiagnostic Test: Molecular assessment of saliva

Interventions

The gustatory and olfactory function will be tested by using the combined Burghart Screening 12 test containing smelling sticks and taste strips (Fa. MediSense, Groningen, Netherlands). Evaluation of taste and smell is performed by offering the sticks/strips and demand a forced multiple choice.

Mild IllnessModerate IllnessSevere Illness

Saliva samples will be taken for molecular biological determination of the oral microbiome. The microbiome is determined at the Institute for Medical Microbiology by 16s-rRNA gene analysis with Next Generation Sequencing and bioinformatics.

Mild IllnessModerate IllnessSevere Illness

Eligibility Criteria

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

Study subjects will be divided into three groups according to the severity grade of illness: non-hospitalized, hospitalized, and intensive care patients.

You may qualify if:

  • All adult COVID-19 recovery patients (exceeding the age of 18) will be included in the study. The time between illness and study recruitment shall be at least 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Justus-Liebig University

Giessen, Hesse, 35392, Germany

RECRUITING

Related Publications (4)

  • Attia S, Howaldt HP. Impact of COVID-19 on the Dental Community: Part I before Vaccine (BV). J Clin Med. 2021 Jan 14;10(2):288. doi: 10.3390/jcm10020288.

    PMID: 33466777BACKGROUND
  • Bottger S, Zechel-Gran S, Streckbein P, Knitschke M, Hain T, Weigel M, Wilbrand JF, Domann E, Howaldt HP, Attia S. A New Type of Chronic Wound Infection after Wisdom Tooth Extraction: A Diagnostic Approach with 16S-rRNA Gene Analysis, Next-Generation Sequencing, and Bioinformatics. Pathogens. 2020 Sep 28;9(10):798. doi: 10.3390/pathogens9100798.

    PMID: 32998201BACKGROUND
  • Ammar N, Aly NM, Folayan MO, Mohebbi SZ, Attia S, Howaldt HP, Boettger S, Khader Y, Maharani DA, Rahardjo A, Khan I, Madi M, Shamala A, Al-Batayneh OB, Rashwan M, Pavlic V, Cicmil S, Galluccio G, Polimeni A, Mancino D, Arheiam A, Dama MA, Nyan M, Phantumvanit P, Kim JB, Choi YH, Castillo JL, Joury E, Abdelsalam MM, Alkeshan MM, Hussein I, Vukovic AP, Iandolo A, Kemoli AM, El Tantawi M. Knowledge of dental academics about the COVID-19 pandemic: a multi-country online survey. BMC Med Educ. 2020 Nov 2;20(1):399. doi: 10.1186/s12909-020-02308-w.

    PMID: 33138810BACKGROUND
  • Ammar N, Aly NM, Folayan MO, Khader Y, Virtanen JI, Al-Batayneh OB, Mohebbi SZ, Attia S, Howaldt HP, Boettger S, Maharani DA, Rahardjo A, Khan I, Madi M, Rashwan M, Pavlic V, Cicmil S, Choi YH, Joury E, Castillo JL, Noritake K, Shamala A, Galluccio G, Polimeni A, Phantumvanit P, Mancino D, Kim JB, Abdelsalam MM, Arheiam A, Dama MA, Nyan M, Hussein I, Alkeshan MM, Vukovic AP, Iandolo A, Kemoli AM, El Tantawi M. Behavior change due to COVID-19 among dental academics-The theory of planned behavior: Stresses, worries, training, and pandemic severity. PLoS One. 2020 Sep 29;15(9):e0239961. doi: 10.1371/journal.pone.0239961. eCollection 2020.

    PMID: 32991611BACKGROUND

MeSH Terms

Conditions

DysgeusiaCOVID-19Oral Manifestations

Condition Hierarchy (Ancestors)

Taste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Dental Polyclinic

Study Record Dates

First Submitted

March 7, 2021

First Posted

March 10, 2021

Study Start

May 1, 2021

Primary Completion

January 30, 2025

Study Completion

May 28, 2025

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations