Therapeutic Effect of Manuka Honey Oral Rinse in Periodontitis Patients Undergoing Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical Attachment Level (CAL)
研究概览
简要总结
Chronic Kidney Disease (CKD) has a strong association with chronic periodontitis, an oral disease causing tooth loss linked to inflammation and malnutrition. While periodontitis affects 12.7% of the general population, its prevalence can rise to 39% in certain racial groups, and a dose-response relationship exists with CKD. End Stage Renal Disease (ESRD) patients show a prevalence of periodontitis ranging from 29% to 85.6%. Uremia, immunosuppression, and vitamin D deficiency are suggested factors in the etiology of periodontitis in CKD patients, with uremic toxins potentially altering the oral ecosystem.
Periodontitis involves bacterial biofilm and Gram-negative anaerobes as primary etiological factors. The main treatment goal is to reduce periodontal pathogens and control inflammation, with non-surgical periodontal therapy (NSPT) being the standard. Although various adjuncts like antibiotics and antiseptics are suggested, recent guidelines only recommend certain locally administered agents and systemic antibiotics for specific groups due to increasing bacterial resistance.
Alternative treatments like honey have gained interest, particularly Manuka honey, known for its antibacterial properties against antibiotic-resistant bacteria. This honey's effectiveness is due to its high sugar concentration, low pH, and formation of hydrogen peroxide. Manuka honey's unique component, methylglyoxal (MGO), is a potent bactericide, virucide, and fungicide, linked to its Non-Peroxide Activity (NPA) and Unique Manuka Factor (UMF) rating. MGO also has immunomodulatory effects beneficial for wound healing and tissue regeneration.
Previous studies show Manuka honey as a promising adjunct in NSPT, improving outcomes significantly without adverse effects. Ongoing research aims to evaluate its effects in ESRD patients on hemodialysis, focusing on clinical attachment levels, other periodontal parameters, and FGF 21 levels in gingival crevicular fluid.
详细描述
Chronic Kidney Disease (CKD) is associated with a high prevalence of chronic periodontitis, an infectious oral disease that causes tooth loss and is linked to inflammation and malnourishment [1]. The frequency of periodontitis is 12.7% in the general population, according to recent epidemiological studies [2], but it can reach as high as 39% in certain racial groups [3, 4], and there is a dose-response relationship with CKD [5]. The prevalence of periodontitis in End Stage Renal Disease (ESRD) has been reported in smaller studies to range from 29 to 85.6% [6, 7, 8]. It has been proposed that uremia and associated immunosuppression, as well as vitamin D deficiency, play a role in the etiology of periodontitis in CKD [5, 9, 10].
Uremic toxins may potentially alter the oral ecosystem (hydrolysis of urea results in alkaline pH) promoting the growth of periodontal pathogens, in a similar manner to the demonstrated uremia-related changes in the gut environment [11, 12]. Studies using microbiological methods of limited scope have shown that ESRD individuals with periodontitis have increased levels of periodontal pathogens as compared to non-CKD controls [13].
Periodontitis is a chronic inflammatory disease affecting the teeth's supporting apparatus. Bacterial biofilm and the associated periodontal pathogenic bacteria, mainly Gram-negative anaerobes, are the main etiological factor of the disease [14].
The main goal of periodontal treatment is to reduce the number of periodontal pathogens and arrest the inflammatory process. The contemporary gold treatment standard is non-surgical periodontal therapy (NSPT), which involves scaling and root planning using manual and machine-driven (sonic or ultrasonic) instruments [15].
Various systemically administered and locally delivered adjuncts to NSPT have been suggested, including systemic and local antibiotics, antiseptics, probiotics, lasers, and photodynamic treatment. However, the latest guidelines on the treatment of periodontitis stage I-III do not support the use of adjuncts. The exception in terms of open recommendations is given for locally administered sustained-release chlorhexidine and antibiotics and the use of systemic antibiotics in specific patient groups [15].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Control Group
Treatment: Normal saline rinse.
Protocol:
Follow the same protocol as the intervention group but using normal saline rinses instead of Manuka honey.
Additional Treatment: Patients will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm.
Supplementary Care: Motivation, oral hygiene instructions (proper tooth brushing technique, flossing, interdental brush, mouthwash usage), scaling, polishing, and root debridement with an ultrasonic scaler and Gracey curettes.
干预措施: Normal saline rinses. (Drug)
Intervention Group
Treatment: Manuka honey oral rinse.
Protocol:
Applied as an oral rinse based on the Biswal et al. administration protocol.
Patients will have oral rinses (20 ml of Manuka honey diluted in 100 ml of purified water) 3 times per day.
Patients will be instructed not to swallow the Manuka honey oral rinse.
Additional Treatment: Patients will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm.
Supplementary Care: Motivation, oral hygiene instructions (proper tooth brushing technique, flossing, interdental brush, mouthwash usage), scaling, polishing, and root debridement with an ultrasonic scaler and Gracey curettes.
干预措施: Manuka honey oral rinse. (Dietary Supplement)
结局指标
主要结局
Clinical Attachment Level (CAL)
时间窗: Evaluated at baseline, 3 months, and 6 months post-treatment.
Description: Measurement of the attachment level of the periodontal ligament to the tooth surface, indicating the health of periodontal tissues.
次要结局
- Fibroblast Growth Factor 23 (FGF 23) Levels in serum(Evaluated at baseline and at 6 months post-treatment.)
- Oral Health Impact Profile (OHIP-14) scores(baseline, and 6 months)
- Serum C-Reactive Protein (CRP)(baseline, 6 months)
- Bleeding on Probing (BOP)(Evaluated at baseline, 3 months, and 6 months post-treatment.)
- Plaque Index(Evaluated at baseline, 3 months, and 6 months post-treatment.)
- Fibroblast Growth Factor 23 (FGF 23) Levels in Gingival Crevicular Fluid (GCF)(Evaluated at baseline and at 6 months post-treatment.)
研究者
Fatma ElSayed
assistant professor
Ain Shams University