Oral Health in Covid-19 Survivors

COVID-19 Clinical Trial

— ORFCovid  

Official title:

Biomarkers of Oral Health in Covid-19 Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205694
• Other study ID #: 36/10
• Status: Recruiting
• Start date: September 20, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2021
• Source: University of Belgrade
• Contact: Jelena Roganovic, Professor
• Phone: +381641976330
• Email: jelena.roganovic[@]stomf.bg.ac.rs
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Periodontitis

Locations

Country	Name	City	State
Serbia	School of Dental Medicine University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal disease stage and COVID 19	Correlation periodontitis and COVID 19 infection	one to six months after COVID-19
Secondary	Oral frailty	Oral frailty assessment in Covid 19 and Perio affected patients	one to six months after COVID-19
Secondary	psychological stress	Assessment of psychological stress	one to six months after COVID-19
Secondary	salivary stress/immunity mediators	Association of salivary stress/immunity mediators levels with perio disease in COVID 19 patients	one to six months after COVID-19