Comparison of Antibacterial Effect of Probiotic Yogurt Against Xylitol-containing Chewing Gum on Salivary Streptococcus Mutans Count, Bacterial Adherence and Salivary pH in Geriatric Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 主要终点
- streptococcus mutans count in saliva
研究概览
简要总结
This study will be conducted to evaluate the antibacterial effect of probiotic bacteria in yogurt in decreasing streptococcus mutans count in saliva and plaque, decreasing bacterial adherence and increasing salivary pH compared to xylitol-containing chewing gum after three months.
详细描述
The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months. The probiotic yogurt is (Activia; Danone, Egypt) containing Bifidobacterium (7x107 CFU/g). The subjects assigned to probiotic yogurt group will be instructed to eat 100 g of the provided yogurt 10 minutes after dinner and not to brush their teeth until one hour later. The subjects assigned to the xylitol-chewing gum group will be instructed to chew the provided gum three times daily for five minutes after each meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
- Allocation concealment: Operator H.M. will choose between numbers in an opaque sealed envelope, which will be arranged by D.K. who will not be involved in any of the phases of the clinical trial. Data will be recorded on a computer by H.M. and O.S. and all records of all patients will be kept with the main supervisor M.I.
- Implementation: D.K. will generate the allocation sequence, enroll participants, and assign participants to interventions.
- Blinding: The assessors M.A. and R.E. will be blinded to the material assignment.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Above 50 years old.
- •Have sufficient cognitive ability to understand consent procedures.
- •Males or Females.
- •Co-operative patients.
- •High caries risk patients (≥105 CFU for streptococcus mutans count)
排除标准
- •Under antibiotic treatment
- •Milk intolerant
- •Consuming any other probiotic product
- •Habitual consumers of xylitol products
- •Use antibacterial mouthwash
- •Lack of compliance
- •Any systemic condition affecting salivary secretion
研究组 & 干预措施
xylitol chewing gum
Xylitol is widely used as an added sweetener in sugar-free products. It has been found to prevent dental caries through reducing dental plaque and limiting salivary streptococcus mutans counts and their produced levels of lactic acid
干预措施: xylitol chewing gum (Dietary Supplement)
probiotic yogurt
Probiotics are live microorganisms that confer oral health benefits by adhering to the oral mucosa and surface of teeth as a part of the biofilm thus preventing the adhesion, colonization, and proliferation of cariogenic bacteria inhibiting the formation of pathogenic plaque
干预措施: Probiotic yogurt (Dietary Supplement)
结局指标
主要结局
streptococcus mutans count in saliva
时间窗: 3 months
The samples will be transported to the laboratory and cultured on selective media (dry Mitis Salivarius Agar with potassium tellurite medium and bacitracin) after serial dilutions. The plates will be incubated at 37ºC in 5-10% CO2 jar. then number of Colony Forming Units (CFU/ml) of Mutans Streptococci in saliva will be determined
次要结局
- streptococcus mutans count in plaque(3 months)
- salivary pH(3 months)
- bacterial adherence(3 months)
研究者
Hadier Mahmoud Ahmed Gad
Internal resident in conservative department
Cairo University