Antibacterial Effect of Probiotic Yogurt Compared to Xylitol

Not Applicable

• Conditions: Geriatric Patients
• Interventions: Dietary Supplement: Probiotic yogurt; Dietary Supplement: xylitol chewing gum

• Registration Number: NCT03889015
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-16
• Study First Submitted QC: 2019-03-21
• Last Update Submitted: 2019-03-22
• Study First Posted: 2019-03-25
• Last Update Posted: 2019-03-26
• Study Start: 2020-06
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic yogurt	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
xylitol chewing gum	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

Primary Outcome Measures

Name	Time	Method
streptococcus mutans count in saliva	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

Secondary Outcome Measures

Name	Time	Method
streptococcus mutans count in plaque	3 months	The samples will then be dispersed and spread over the culture media plates (mitis salivarius-bacitracin Agar), and the plates will be incubated under aerobic conditions
salivary pH	3 months	All the saliva samples will be tested on the same day for salivary pH using digital pH meter. The equipment will be calibrated with distilled water to reach pH 7 every time before measuring each sample
bacterial adherence	3 months	After applying disclosing agent over teeth, standard photographic images of the maxillary and mandibular facial surfaces of teeth will be taken. Digital plaque image analysis will be used to analyze plaque coverage. Images will be converted into pixels to calculate the percentage of the tooth covered with plaque divided by the total tooth area (both tooth areas with and without plaque) as follows: plaque area coverage = \[plaque pixels / (tooth pixels + plaque pixels)\] × 100 The computer analysis results will be checked for consistency and accuracy by an expert in image analysis who is blinded to the assigned treatment