COVID-19ORFCovidNCT05205694
Oral Health in Covid-19 Survivors
An observational study of COVID-19 and Periodontitis, run by University of Belgrade at 1 site in Serbia.
Trial summary
Aims are to assess periodontal health and salivary stress/ immunity responses in COVID-19 survivors Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Periodontitis
- How many people
- 210 participants
- Where
- 1 siteSerbia
- Study dates
- 20 Sep 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- history of periodontal treatment in previous six months, acute oral infection, presence of systemic disease(s), pregnancy, lactation, smoking ≥ 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
School of Dental Medicine University of Belgrade
Belgrade, 11000
Jelena Roganović, Professor
About this study
Official title: Biomarkers of Oral Health in Covid-19 Survivors
Aims are to assess periodontal health and salivary stress/ immunity responses in COVID-19 survivors
Read the detailed 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.
- Conditions
- COVID-19, Periodontitis
- Medical subject headings
- COVID-19, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal disease stage and COVID 19
Correlation periodontitis and COVID 19 infection
Measured: one to six months after COVID-19
Secondary outcomes (3)
Oral frailty
Oral frailty assessment in Covid 19 and Perio affected patients
Measured: one to six months after COVID-19
psychological stress
Assessment of psychological stress
Measured: one to six months after COVID-19
salivary stress/immunity mediators
Association of salivary stress/immunity mediators levels with perio disease in COVID 19 patients
Measured: one to six months after COVID-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start20 Sep 2021
- Primary completion31 May 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jelena Roganović, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205694
- Sponsor's protocol ID
- 36/10
- Acronym
- ORFCovid
- Status last verified
- Sep 2021
- First submitted
- 22 Jan 2022
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Oral Health in Covid-19 Survivors
- ClinicalTrials.gov ID
- NCT05205694
- Acronym / sponsor ID
- ORFCovid / 36/10
- Conditions
- COVID-19, Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims are to assess periodontal health and salivary stress/ immunity responses in COVID-19 survivors
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- history of periodontal treatment in previous six months, acute oral infection, presence of systemic disease(s), pregnancy, lactation, smoking ≥ 10 cigarettes per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Periodontal disease stage and COVID 19
Time frame: one to six months after COVID-19
Correlation periodontitis and COVID 19 infection
3 secondary outcomes
Oral frailty
Time frame: one to six months after COVID-19
psychological stress
Time frame: one to six months after COVID-19
salivary stress/immunity mediators
Time frame: one to six months after COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Periodontitis, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jelena Roganović, Professor (+381641976330, jelena.roganovic@stomf.bg.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal disease stage and COVID 19 (time frame: one to six months after COVID-19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.