Oral and Olfactory Complications of Recovered COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04791436

Recruitment Status : Recruiting

First Posted : March 10, 2021

Last Update Posted : November 5, 2021

See Contacts and Locations

Sponsor:

Collaborators:

Masaryk University

University of Kiel

Information provided by (Responsible Party):

Sameh Attia, University of Giessen

Study Description

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.

Condition or disease	Intervention/treatment
Oral Complication Dysgeusia Olfactory Disorder	Diagnostic Test: Gustatory and olfactory function test Diagnostic Test: Molecular assessment of saliva

Detailed Description:

This prospective 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.

Study objectives:

To describe the frequency and severity of oral signs and chemosensory disorders that persist after the recovery of COVID-19 and to examine whether "taste disorders" can be discriminated into an- or hypogeusia and an- or hyposmia.
To report any correlation between the severity grade of COVID-19 and the resulting standing symptoms.
To describe the oral microbiome after infection with COVID-19 and to describe possible changes in comparison to normal healthy individuals.

Clinical and -if indicated- radiological examination to assess the long-term oral and chemosensory impairment and complaints of COVID-19 patients after their recovery shall be performed in an interdisciplinary setting of Maxillofacial Surgery, ENT and Medical Microbiology.

The study subjects will be divided into three groups according to the severity grade of illness: non-hospitalized, hospitalized, and intensive care patients. 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. Exclusion criteria are psychiatric or neurological diseases, previous trauma, surgery or radiotherapy in the oral or nasal cavities, pre-existing taste or smell dysfunctions or chronic rhinosinusitis.

The study variables include age, sex, co-morbidities, possible causes of exclusion from the study. The oral health assessment will be performed by examination of: periodontal status, assessment of oral lesions, a radiological examination by using panoramic x-ray if clinically indicated, photo documentation, objective evaluation of the olfactory and gustatory functions with psychophysical tests. 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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	402 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Oral and Olfactory Complications of Recovered COVID-19 Patients: A Prospective Cohort Study
Actual Study Start Date :	May 1, 2021
Estimated Primary Completion Date :	December 30, 2021
Estimated Study Completion Date :	February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Mild Illness Recovered COVID-19 patients who experienced a mild clinical course	Diagnostic Test: Gustatory and olfactory function test 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. Diagnostic Test: Molecular assessment of saliva 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.
Moderate Illness Recovered COVID-19 patients who experienced a moderate clinical course	Diagnostic Test: Gustatory and olfactory function test 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. Diagnostic Test: Molecular assessment of saliva 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.
Severe Illness Recovered COVID-19 patients who experienced a severe clinical course	Diagnostic Test: Gustatory and olfactory function test 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. Diagnostic Test: Molecular assessment of saliva 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.

Outcome Measures

Primary Outcome Measures :

Periodontal health [ Time Frame: At least 3 months after recovery of COVID-19 ]
Community Periodontal Index (CPI) of the World Health Organization (WHO) will be used to assess periodontal health (continuous variable)
Oral mucocutaneous lesions [ Time Frame: At least 3 months after recovery of COVID-19 ]
An intraoral examination will be carried out to assess the presence of any mucocutaneous lesions (dichotomous variable)
Gustatory function [ Time Frame: At least 3 months after recovery of COVID-19 ]
Burghart Sniffin' Sticks "Screening 12 Test" will be used to assess gustatory function (continuous variable)
Olfactory function [ Time Frame: At least 3 months after recovery of COVID-19 ]
Burghart Sniffin' Sticks "Screening 12 Test" will be used to assess olfactory function (continuous variable)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability 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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Exclusion criteria are psychiatric or neurological diseases, previous trauma, surgery or radiotherapy in the oral or nasal cavities, pre-existing taste or smell dysfunctions or chronic rhinosinusitis.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791436

Contacts

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Contact: Sameh Attia, MSc	00496419946110	Sameh.Attia@dentist.med.uni-giessen.de

Locations

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Germany
Justus-Liebig University	Recruiting
Gießen, Hesse, Germany, 35392
Contact: Sameh Attia

Sponsors and Collaborators

University of Giessen

Masaryk University

University of Kiel

More Information

Additional Information:

Impact of COVID-19 on The Dental Community This link exits the ClinicalTrials.gov site

Publications:

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). pii: E288. doi: 10.3390/jcm10020288.

Böttger 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). pii: E798. doi: 10.3390/pathogens9100798.

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.

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.

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Responsible Party:	Sameh Attia, Head of the Dental Polyclinic, University of Giessen
ClinicalTrials.gov Identifier:	NCT04791436
Other Study ID Numbers:	OORCV
First Posted:	March 10, 2021 Key Record Dates
Last Update Posted:	November 5, 2021
Last Verified:	October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Sameh Attia, University of Giessen:


COVID-19 Oral Manifestations Olfactory Manifestations

Additional relevant MeSH terms:

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COVID-19 Dysgeusia Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections	Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Taste Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases

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