Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05278468 |
| Other study ID # |
24081992 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2022 |
| Est. completion date |
October 15, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
