The British University in Egypt
Cairo, 3753450, Egypt
NCT Number: NCT06129097
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.
Looking for future studies?
Notify Me19 year and older
All sexes
Interventional
Not applicable
Cairo, 3753450, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 weeks
With a periodontal probe, PD and CAL will be measured on six locations of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal).
Time frame: 6 weeks
The proportion of bleeding sites 10 second after being stimulated by a standardized manual probe with a controlled force to the bottom of the sulcus/pocket at six locations (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) on all present teeth will be assessed dichotomously as a BOP score on all present teeth
Time frame: 6 weeks
presence of plaque is scored on a dichotomous variable and the final score per individual is the sum of the plaque scores divided by the number of surfaces examined.
Time frame: 6 weeks
British University In Egypt
Other
Thyme Honey Mouthwash in Management of Periodontitis in Renal Patients on Hemodialysis: A Randomized Controlled Clinical Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05816941
Diabetes Mellitus, Diabetes Mellitus, Type 2
View Trial DetailsNCT05932017
Alveolar Bone Loss, Bone Diseases
Dallas, Texas, United States
View Trial DetailsNCT05631600
Alveolar Bone Loss, Bone Diseases
Zagreb, Croatia
View Trial DetailsNCT04712630
Mouth Diseases, Periodontal Atrophy
Murcia, Spain
View Trial Details