Oral Health in Covid-19 Survivors

NCT05205694 | Unknown

• 1 other identifier: 36/10
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Periodontal disease stage and COVID 19

  Correlation periodontitis and COVID 19 infection

  one to six months after COVID-19

Secondary Outcomes (3)

• Oral frailty

  one to six months after COVID-19

• psychological stress

  one to six months after COVID-19

• salivary stress/immunity mediators

  one to six months after COVID-19

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Groups I and III will include COVID-19 survivors in late convalescent stage (one to six months post onset of symptoms accompanied by SARS-CoV-2- positive nasopharyngeal swab result) who had non-severe COVID-19 (no or mild pneumonia - less than 50 percent lung involvement on imaging within 24 to 48 hours, absence of dyspnea and hypoxia). Groups II and IV will include participants who report to had no symptoms of COVID-19 and had no SARS-CoV-2- positive nasopharyngeal swab result

You may qualify if:

• 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.

You may not qualify if:

• history of periodontal treatment in previous six months, acute oral infection, presence of systemic disease(s), pregnancy, lactation, smoking ≥ 10 cigarettes per day

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

School of Dental Medicine University of Belgrade

Belgrade, 11000, Serbia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

COVID-19; Periodontitis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Jelena Roganović, Professor

CONTACT

+381641976330; jelena.roganovic@stomf.bg.ac.rs

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: January 25, 2022
• Study Start: September 20, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2023
• Last Updated: January 25, 2022

Record last verified: 2021-09

Locations

SE (1)