Oral and Olfactory Complications of Recovered COVID-19 Patients

Olfactory Disorder Clinical Trial

Official title:

Oral and Olfactory Complications of Recovered COVID-19 Patients: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791436
• Other study ID #: OORCV
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: May 28, 2025

Study information

• Verified date: May 2024
• Source: University of Giessen
• Contact: Sameh Attia, MSc
• Phone: 00496419946110
• Email: Sameh.Attia[@]dentist.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

1. 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.

2. To report any correlation between the severity grade of COVID-19 and the resulting standing symptoms.

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 402
• Est. completion date: May 28, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Dysgeusia
• Olfactory Disorder
• Oral Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Justus-Liebig University	Gießen	Hesse

Sponsors (3)

Lead Sponsor	Collaborator
University of Giessen	Masaryk University, University of Kiel

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Impact of COVID-19 on The Dental Community