PeriodontitisNCT05278468
Association Between Periodontitis and Coronavirus Disease (COVID-19)
An observational study of Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
The study is a case control study investigating the association between Periodontitis and Coronavirus disease (COVID-19) in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- PCR test for covid-19
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2022to 15 Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting the dedicated COVID Outpatient Clinic who will undergo real-time reverse transcription polymerase chain reaction (rRT-PCR) for the diagnosis of COVID-19 will be recruited for the study. Subsequently, prior to data analysis, the patients for whom complete set of data will be available will be categorized as either case or control depending on the results of rRT-PCR test by the supervisor. Patients who will have positive rRT-PCR results will be included in the case group, and patients with negative results will be included in the control group. Patients in the control group will be scheduled for an oral examination after the negative rRT-PCR, and patients who were positive for the virus (case group) will be scheduled for an oral examination after the completion of treatment when they will be determined to be disease free through a negative rRT-PCR. peridontal examination will be performed.
Who may be able to join
- Patients aged 18 years old and above.
- Patient consulting in the outpatient clinic
- Provide informed consent.
Who cannot join
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
- Completely edentulous patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Periodontitis and Coronavirus Disease (COVID-19) On A Sample of Adult Egyptian Patients: A Case Control Study
The study is a case control study investigating the association between Periodontitis and Coronavirus disease (COVID-19) in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University.
Read the detailed description
The coronavirus disease of 2019 (COVID-19) has become a new global issue since its outbreak in Wuhan, China, and has claimed millions of lives as a result. Despite having a low fatality rate of 2.1 percent (WHO), the disease has imposed an unacceptable cost on the world due to its high transmissibility and associated morbidity. The causal virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), affects not only the respiratory system but also the cerebrovascular system and other important organs
Coronavirus is a highly contagious single-stranded RNA virus that causes mild to severe respiratory infections in humans and animals. SARS-CoV-2, a novel strand of the -coronavirus family, was discovered in Wuhan, China, in late 2019 which spread fast over the world, forcing WHO to designate the disease a global pandemic on March 11, 2020
The SARS-CoV-2 virus infects host cells by adhering to S-protein, a viral transmembrane spike (S) glycoprotein that clings to human cells by binding to angiotensin converting enzyme II (ACE2), a membrane protein that acts as a virus receptor (Walls et al., 2020). To enable viral fusion into target cells, host proteases such as TMPRSS2, cathepsin L, or proprotein convertase furin proteolytically break the S-protein after it binds to ACE2 . SARS-CoV-2 can also boost the expression of ACE2, making it easier for the virus to invade host cells.
Periodontal disease has been proved to be the most common oral condition of human population . It was widely spread in both the developed and developing countries. High prevalence of periodontal disease has been found in adolescents, adults, and older individuals. Smoking, poor oral hygiene, diabetes, medication, age, hereditary and stress were all considered to be the risk factors of periodontal diseases. Overall, they affected about 20-50% of the population around the globe
Gingivitis and Periodontitis are the most common forms of human periodontal diseases. Inflammation of the gingiva is called gingivitis. The gingiva includes all soft tissue surrounding the tooth coronal to the crest of alveolar bone and to a varying extent lateral to the bone, extending to the mucogingival junction. While, the periodontium includes cementum, periodontal ligament, alveolar bone and the gingiva. Periodontitis includes loss of attachment of periodontal tissues from the tooth together with net loss of alveolar bone height. That's why Gingivitis was found to be reversible, while regeneration after the periodontitis destruction was not predictably achievable . The prevalence of periodontitis has been reported by the World Health Organization (WHO) which showed a prevalence of severe periodontitis in around 8-10% of the Population.
Staging was primarily based on presentation of disease severity as well as disease management sophistication. While the grading offered details about the disease's biological characteristics, including a history-based overview of disease progression risk. This classification also assessed the risk of further development of the disease or any potential negative treatment outcomes and how the disease or its treatment could adversely affect the patient's overall health.
Tonetti stated that staging includes four categories (stages I through IV) and is determined by taking into account several variables, including CAL, amount and percentage of bone loss, PD, existence and degree of angular bony defects, involvement of furcation, mobility of the tooth and loss of the tooth due to periodontitis. On this basis, stage I means initial periodontitis, stage II means moderate periodontitis, stage III means severe periodontitis with potential for additional tooth loss while stage IV means severe periodontitis with potential for loss of dentition. Therefore, data on tooth loss, that can be specifically attributed to periodontitis might alter the concept of the stage.
A periodontitis stage I is characterized by interdental CAL from 1 to 2 mm, radiographic bone loss in the coronal third < 15%, PD ≤ 4 mm and mostly horizontal bone loss, however no tooth loss due to periodontitis is detected at this stage. While, a periodontitis stage II case is characterized by interdental CAL from 3 to 4 mm, radiographic bone loss in the coronal third from 15% to 33%, PD ≤ 5mm and mostly horizontal bone loss, however no tooth loss due to periodontitis is detected at this stage. On the other hand, stages III \& IV are characterized by interdental CAL ≥ 5 mm and radiographic bone loss extending to the middle or apical third of the root. In stage III, four teeth or less are lost due to periodontitis while in stage IV, five teeth or more are lost due to periodontitis. In addition to stage II complexity, Stage III is characterized by PD ≥ 6 mm, vertical bone loss ≥ 3mm, furcation involvement class II or III and moderate ridge defect. In addition to stage III complexity, stage IV is characterized by severe ridge defect, bite collapse with drifting and flaring of teeth
The immune system and the inflammatory response to these disorders could be a relationship between periodontitis and COVID-19 severity. The synergy between severe COVID-19 and periodontal disease has been theorised to be the outcome of their immunological activation . In 2021 Hu stated that exaggerated immune responses, such as cytokine storm, which is a prevalent pathway in many inflammatory illnesses, are also identified as one of COVID-19's key tissue-damaging mechanisms. COVID-19 and periodontal diseases have similar proinflammatory cytokine production and influence systemic health, according to research.
Periodontal pockets have the potential to function as viral reservoirs. From pockets of severe periodontitis (Stage 3 and 4) patients, herpes simplex virus (HSV), active human cytomegalovirus (HCMV), and other viral species have been discovered. they theorised that periodontal pockets could act as a reservoir for SARS-CoV-2, increasing viral burden in affected people.
Severe systemic inflammation and thrombotic lesions are the main causes of COVID-19 consequences such acute respiratory distress syndrome and multiorgan failure These issues are linked to a number of risk factors and diseases, many of which are also linked to periodontitis. These links between periodontitis and COVID-19 complications could be due to a direct effect of periodontitis on systemic inflammation, an indirect effect of periodontitis on other COVID-19 risk factors, or predisposing conditions that are common to both periodontitis and COVID-19, such as diabetes and genetic variants
Since the beginning of the pandemic, several investigations have supported the link between COVID-19 and periodontal disorders. Increased gingival bleeding was reported in three case reports among COVID-19 patients. After the viral infection stopped, this condition improved clinically . However, these findings were insufficient to establish a link between periodontitis and COVID-19, especially as individuals with COVID-19 are more inclined to ignore dental hygiene when their health is impacted by COVID-19 symptoms. In fact, patients with COVID-19 have higher oral plaque ratings and gingival edema than their matched SARS-CoV 2 negative controls, according to a recent study made by Anand in 2021. This link between COVID-19 and periodontitis does not imply causation, but it does suggest that more research is needed The study aims at determining whether periodontitis and poor oral hygiene are associated with COVID-19.
- Conditions
- Periodontitis
- Being tested
- PCR test for covid-19
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR test for covid-19Other
real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection.
| Study group | Role | What they receive |
|---|---|---|
| case group | Adult Egyptian participants attending the diagnostic center at faculty of Dentistry, Cairo University who had positive real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection. Receives: Other: PCR test for covid-19 | |
| control group | Adult Egyptian participants attending the diagnostic center at faculty of Dentistry, Cairo University with negative positive real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection. Receives: Other: PCR test for covid-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between Poor oral hygiene and Coronavirus disease (COVID-19).
after periodontal examination to the 2 groups who are subjected to PCR tests, will we find association between them
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start15 Aug 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Khaled Gamil Moussa Megahed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278468
- Sponsor's protocol ID
- 24081992
- Status last verified
- Feb 2023
- First submitted
- 11 Mar 2022
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Periodontitis and Coronavirus Disease (COVID-19) On A Sample of Adult Egyptian Patients: A Case Control Study
- ClinicalTrials.gov ID
- NCT05278468
- Acronym / sponsor ID
- 24081992
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 14 Mar 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.
The study is a case control study investigating the association between Periodontitis and Coronavirus disease (COVID-19) in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University.
Detailed description
The coronavirus disease of 2019 (COVID-19) has become a new global issue since its outbreak in Wuhan, China, and has claimed millions of lives as a result. Despite having a low fatality rate of 2.1 percent (WHO), the disease has imposed an unacceptable cost on the world due to its high transmissibility and associated morbidity. The causal virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), affects not only the respiratory system but also the cerebrovascular system and other important organs
Coronavirus is a highly contagious single-stranded RNA virus that causes mild to severe respiratory infections in humans and animals. SARS-CoV-2, a novel strand of the -coronavirus family, was discovered in Wuhan, China, in late 2019 which spread fast over the world, forcing WHO to designate the disease a global pandemic on March 11, 2020
The SARS-CoV-2 virus infects host cells by adhering to S-protein, a viral transmembrane spike (S) glycoprotein that clings to human cells by binding to angiotensin converting enzyme II (ACE2), a membrane protein that acts as a virus receptor (Walls et al., 2020). To enable viral fusion into target cells, host proteases such as TMPRSS2, cathepsin L, or proprotein convertase furin proteolytically break the S-protein after it binds to ACE2 . SARS-CoV-2 can also boost the expression of ACE2, making it easier for the virus to invade host cells.
Periodontal disease has been proved to be the most common oral condition of human population . It was widely spread in both the developed and developing countries. High prevalence of periodontal disease has been found in adolescents, adults, and older individuals. Smoking, poor oral hygiene, diabetes, medication, age, hereditary and stress were all considered to be the risk factors of periodontal diseases. Overall, they affected about 20-50% of the population around the globe
Gingivitis and Periodontitis are the most common forms of human periodontal diseases. Inflammation of the gingiva is called gingivitis. The gingiva includes all soft tissue surrounding the tooth coronal to the crest of alveolar bone and to a varying extent lateral to the bone, extending to the mucogingival junction. While, the periodontium includes cementum, periodontal ligament, alveolar bone and the gingiva. Periodontitis includes loss of attachment of periodontal tissues from the tooth together with net loss of alveolar bone height. That's why Gingivitis was found to be reversible, while regeneration after the periodontitis destruction was not predictably achievable . The prevalence of periodontitis has been reported by the World Health Organization (WHO) which showed a prevalence of severe periodontitis in around 8-10% of the Population.
Staging was primarily based on presentation of disease severity as well as disease management sophistication. While the grading offered details about the disease's biological characteristics, including a history-based overview of disease progression risk. This classification also assessed the risk of further development of the disease or any potential negative treatment outcomes and how the disease or its treatment could adversely affect the patient's overall health.
Tonetti stated that staging includes four categories (stages I through IV) and is determined by taking into account several variables, including CAL, amount and percentage of bone loss, PD, existence and degree of angular bony defects, involvement of furcation, mobility of the tooth and loss of the tooth due to periodontitis. On this basis, stage I means initial periodontitis, stage II means moderate periodontitis, stage III means severe periodontitis with potential for additional tooth loss while stage IV means severe periodontitis with potential for loss of dentition. Therefore, data on tooth loss, that can be specifically attributed to periodontitis might alter the concept of the stage.
A periodontitis stage I is characterized by interdental CAL from 1 to 2 mm, radiographic bone loss in the coronal third < 15%, PD ≤ 4 mm and mostly horizontal bone loss, however no tooth loss due to periodontitis is detected at this stage. While, a periodontitis stage II case is characterized by interdental CAL from 3 to 4 mm, radiographic bone loss in the coronal third from 15% to 33%, PD ≤ 5mm and mostly horizontal bone loss, however no tooth loss due to periodontitis is detected at this stage. On the other hand, stages III \& IV are characterized by interdental CAL ≥ 5 mm and radiographic bone loss extending to the middle or apical third of the root. In stage III, four teeth or less are lost due to periodontitis while in stage IV, five teeth or more are lost due to periodontitis. In addition to stage II complexity, Stage III is characterized by PD ≥ 6 mm, vertical bone loss ≥ 3mm, furcation involvement class II or III and moderate ridge defect. In addition to stage III complexity, stage IV is characterized by severe ridge defect, bite collapse with drifting and flaring of teeth
The immune system and the inflammatory response to these disorders could be a relationship between periodontitis and COVID-19 severity. The synergy between severe COVID-19 and periodontal disease has been theorised to be the outcome of their immunological activation . In 2021 Hu stated that exaggerated immune responses, such as cytokine storm, which is a prevalent pathway in many inflammatory illnesses, are also identified as one of COVID-19's key tissue-damaging mechanisms. COVID-19 and periodontal diseases have similar proinflammatory cytokine production and influence systemic health, according to research.
Periodontal pockets have the potential to function as viral reservoirs. From pockets of severe periodontitis (Stage 3 and 4) patients, herpes simplex virus (HSV), active human cytomegalovirus (HCMV), and other viral species have been discovered. they theorised that periodontal pockets could act as a reservoir for SARS-CoV-2, increasing viral burden in affected people.
Severe systemic inflammation and thrombotic lesions are the main causes of COVID-19 consequences such acute respiratory distress syndrome and multiorgan failure These issues are linked to a number of risk factors and diseases, many of which are also linked to periodontitis. These links between periodontitis and COVID-19 complications could be due to a direct effect of periodontitis on systemic inflammation, an indirect effect of periodontitis on other COVID-19 risk factors, or predisposing conditions that are common to both periodontitis and COVID-19, such as diabetes and genetic variants
Since the beginning of the pandemic, several investigations have supported the link between COVID-19 and periodontal disorders. Increased gingival bleeding was reported in three case reports among COVID-19 patients. After the viral infection stopped, this condition improved clinically . However, these findings were insufficient to establish a link between periodontitis and COVID-19, especially as individuals with COVID-19 are more inclined to ignore dental hygiene when their health is impacted by COVID-19 symptoms. In fact, patients with COVID-19 have higher oral plaque ratings and gingival edema than their matched SARS-CoV 2 negative controls, according to a recent study made by Anand in 2021. This link between COVID-19 and periodontitis does not imply causation, but it does suggest that more research is needed The study aims at determining whether periodontitis and poor oral hygiene are associated with COVID-19.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Other: PCR test for covid-19Adult Egyptian participants attending the diagnostic center at faculty of Dentistry, Cairo University who had positive real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection. |
| control group | – | Other: PCR test for covid-19Adult Egyptian participants attending the diagnostic center at faculty of Dentistry, Cairo University with negative positive real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the dedicated COVID Outpatient Clinic who will undergo real-time reverse transcription polymerase chain reaction (rRT-PCR) for the diagnosis of COVID-19 will be recruited for the study. Subsequently, prior to data analysis, the patients for whom complete set of data will be available will be categorized as either case or control depending on the results of rRT-PCR test by the supervisor. Patients who will have positive rRT-PCR results will be included in the case group, and patients with negative results will be included in the control group. Patients in the control group will be scheduled for an oral examination after the negative rRT-PCR, and patients who were positive for the virus (case group) will be scheduled for an oral examination after the completion of treatment when they will be determined to be disease free through a negative rRT-PCR. peridontal examination will be performed.
Key inclusion criteria (3 listed)
- Patients aged 18 years old and above.
- Patient consulting in the outpatient clinic
- Provide informed consent.
Key exclusion criteria (3 listed)
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
- Completely edentulous patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR test for covid-19real-time reverse transcription polymerase chain reaction results for severe acute respiratory syndrome coronavirus-19 (COVID-19) infection. | Other | case group, control group |
Primary outcome
The association between Poor oral hygiene and Coronavirus disease (COVID-19).
Time frame: 1 year
after periodontal examination to the 2 groups who are subjected to PCR tests, will we find association between them
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Feb 2023. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between Poor oral hygiene and Coronavirus disease (COVID-19). (time frame: 1 year). 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 8 Feb 2023.