Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06129097 |
| Other study ID # |
23-063 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
March 1, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
British University In Egypt |
| Contact |
Asmaa Ras, Phd |
| Phone |
01098015060 |
| Email |
asmaa.aboubakr[@]bue.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There is a known correlation between oral health and systemic disease. Particularly
significant evidences associate periodontal bacteria and tooth loss to systemic disorders and
specifically to cardiovascular disease, such as high BP. Furthermore, a correlation between
periodontal disease and hypertension has been recently reported ESRD and the medications used
by those patients create complications in a variety of systems and organs, which frequently
worsens or causes new pathologies in the oral cavity, such as caries, periodontal disease,
and different mucosal lesions.
Therefore, the current trial was set up to first evaluate the effect of thyme honey oral
rinse in ESRD patients with periodontitis using CAL as a primary objective, and to evaluate
the clinical effectiveness of thyme honey oral rinse in ESRD patients with periodontitis on
bleeding on probing (BOP) and plaque index, and salivary NO levels as secondary objectives.
Description:
Periodontal diseases can be seen in up to 90% of the global population, making it the most
common oral disease. In the United States alone, cross-sectional studies show that
approximately 50% of adults currently have some form of gingivitis, and up to 80% have
experienced some form of periodontal disease in their life. Certain groups have been shown to
have an increased incidence of periodontal diseases.
There is a known correlation between oral health and systemic disease . Particularly
significant evidences associate periodontal bacteria and tooth loss to systemic disorders and
specifically to cardiovascular disease, such as high BP. Furthermore, a correlation between
periodontal disease and hypertension has been recently reported.
ESRD and the medications used by those patients create complications in a variety of systems
and organs, which frequently worsens or causes new pathologies in the oral cavity, such as
caries, periodontal disease, and different mucosal lesions.
The emergence of a chronic systemic inflammatory disease in people with ESRD is a common
occurrence. The reasons of this inflammation are most likely multifaceted and complex. A
number of illnesses and comorbidities have been identified as potential influencers of an
increase in the inflammatory state.
The accelerated periodontal disease with pocket formation, gingival recession, and bone and
tooth loss is due not only to inadequate oral hygiene and inflammatory disease burden but
also to renal osteodystrophy, high urea concentration, salivary changes in composition and
the host factors related to the underlying systemic disease that modify the host response to
periodontal infection.
Through nitrate-nitrite reduction, some commensal oral bacteria can supply bioactive NO,
essential for the endothelial cell function and regulation of arterial BP.
NO is a free radical and simple gas that is synthesized endogenously by a family of enzymes
namely NOSs. Normally, NO is produced from the amino acid L-arginine in the presence of
oxygen by eNOS and it has an important role in preserving vascular homeostasis. NO is a
multifunctional signaling molecule involved in the maintenance of metabolic and
cardiovascular homeostasis and also a potent endogenous vasodilator that suppresses the
formation of vascular lesions in atherosclerosis. Imbalance in NO bioavailability is
associated with some cardiovascular and metabolic diseases.
Reduction of oxygen provision, such as in the case of myocardial ischaemia, compromises NO
synthesis.
Decreased production or activity of NO, due to endothelial dysfunction, is responsible for
the pathogenesis of many cardiovascular diseases, including atherosclerosis and CVD such as
hypertension, coronary artery disease.
The prospective to restore the oral microbiome by probiotics to increase NO bioavailability
represents a new strategy in cardiovascular medicine and dentistry. Therefore, providing NO
generation by using nitrite and nitrate may be considered a potential therapeutic approach to
the management of resistant hypertensive patients.
The anti-inflammatory properties of thyme extracts due to that thyme exerted a dose-dependent
decrease in the production and gene expression of the proinflammatory mediators' tumor
necrosis factor (TNF)-α, IL-1B, and IL-6 associated with an increase in the anti-inflammatory
IL-10 cytokine secretion in activated macrophages, suggesting beneficial application of thyme
honey as an oral health aid.
Thyme honey is an Iranian domestic honey produced from the nectar of different species of
thyme plants. Its components are different from thyme extract in quantities. The major
constituents of thyme extract are phenolic compounds (such as thymol). However, thyme honey
may contain some of these essential oil components at a lower concentration Therefore, the
current trial was set up to first evaluate the effect of thyme honey oral rinse in ESRD
patients with periodontitis using CAL as a primary objective, and to evaluate the clinical
effectiveness of thyme honey oral rinse in ESRD patients with periodontitis on bleeding on
probing (BOP) and plaque index, and salivary NO levels as secondary objectives.
