Effectiveness of Thyme Honey in Management of Xerostomia in Geriatric Patients With ESRD: Longitudinal Prospective Clinical Biochemical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in subjective dry mouth score
研究概览
简要总结
The oral health of older people has warranted considerable research attention in the last two to three decades. One of the most oral conditions that have been related to the elderly patients was xerostomia.
An elderly population that has a high rate of comorbid disease is likely to continue for the foreseeable future. Among these pathologies, End stage renal disease (ESRD) stands out as a common serious age-related disease. ESRD is a chronic irreversible renal failure. It is known also as chronic kidney disease (CKD) Stage 6 or CKD 6. Xerostomia is relatively common in patients having ESRD with prevalence ranging from 28% to 67%.
Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients with ESRD which were based on the stimulation of the salivary gland flow.
A new alternative for the control of xerostomia is the use of thyme honey, which is a propolis gel product with strong antioxidant, antibacterial, antifungal and immunomodulation effect. It is believed that the presence of honey in the oral cavity has a sialagogue effect, stimulating the salivary glands to produce more saliva, due to the high sugar concentration in honey.
The purpose of the study is to determine whether the use of thyme honey as mouth rinse will help in the treatment of xerostomia in geriatric patients with end-stage renal disease (symptom management).
详细描述
Most patients with end-stage renal disease (ESRD) on hemodialysis (HD) have to maintain a fluid-restricted diet in order to prevent fluid overload between dialysis sessions. . However, compliance to the fluid restriction is also influenced by other factors, such as hormonal derangements, social and psychological changes, thirst and xerostomia.
Xerostomia in ESRD is a multifactorial phenomenon and various mechanisms contribute to its development as direct uremic involvement of salivary glands, atrophy and fibrosis of the salivary glands, chemical inflammation, dehydration, mouth breathing. The other conditions that may cause dry mouth in uremic patients are retrograde parotitis, metabolic abnormalities, use of diuretics and due to inability of kidneys to reabsorb sodium and the resultant polyuria.
Xerostomia, the subjective feeling of oral dryness, is a symptom most frequently accompanied by either decreased salivary flow or an altered composition of saliva. Hyposalivation, on the other hand, is the objective measured reduction in salivary flow rate. Xerostomia is a relatively common complaint, particularly among older people, and can lead to major consequences with regard to the quality of their general and oral health and wellbeing.
Xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. Primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, Sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis C virus infection, and HIV disease.
Secondary causes of xerostomia include the side-effects of radiation therapy or chemotherapy, rheumatoid arthritis, scleroderma, mixed connective tissues diseases, systemic lupus erythematous, graft versus host disease, anorexia, alcohol and smoking and commonly prescribed drugs (>500 medications reportedly cause dry mouth). The most common medications causing hyposalivation are those with anticholinergic activity, sympathomimetics, and benzodiazepines. The risk of xerostomia increases with the synergistic effects of xerogenic medications, multiple medications, higher doses of medication, and the duration of the medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders, of minimum 61 years.
- •All patients must be clinically diagnosed of ESRD undergoing hemodialysis.
- •Patients on hemodialysis ≥ 3 months (Bots et al., 2005).
- •All patients must have complaint of xerostomia.
- •Objective dry mouth score from ( 2-5).
- •Subjective dry mouth score from (1-4).
- •Patients must be able to make reliable decision or communications.
排除标准
- •- Smoking, Alcohol. Healthy patients.
- •Patient with history of any serious illness as malignancy, who undergo kidney transplant.
- •Patients with any autoimmune disease.
- •Patients with diabetes mellitus (Charalambous et al., 2017).
- •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
Changes in subjective dry mouth score
时间窗: one month
Changes in subjective dry mouth score \[ Time Frame: baseline, 2 weeks and 4 weeks after intervention\] The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of thyme honey mouth rinse (for at least 5 days per week)
次要结局
- Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method(one month)
- Changes in objective dry mouth score(one month)
- Changes in salivary Potential of Hydrogen ion (pH)(one month)
- Increase in unstimulated Salivary Flow Rate (ml/min)(one month)