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临床试验/NCT06129097
NCT06129097已完成不适用

Thyme Honey Mouthwash in Management of Periodontitis in Renal Patients on Hemodialysis: A Randomized Controlled Clinical Trial.

British University In Egypt2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Clinical attachment loss (CAL)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The clinical outcome assessor (A.A) will not be aware of which treatment will be being administered, thus yielding a single-blind controlled study.

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Both genders, aged above 18 years.
  • All patients must be clinically diagnosed of ESRD undergoing hemodialysis.
  • All patients must have a periodontal disease.
  • Patients must be able to make reliable decision or communications.

排除标准

  • - Smoking, Alcohol.
  • Patient with history of any serious illness as malignancy, who undergo kidney transplant.
  • Patients with any autoimmune disease.
  • Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
  • Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

结局指标

主要结局

Clinical attachment loss (CAL)

时间窗: 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).

次要结局

  • Plaque index(6 weeks)
  • Bleeding on probing(6 weeks)
  • Salivary Nitric oxide levels(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa bakr

Lecturer Assistant

British University In Egypt

研究点 (2)

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