Antibacterial Effect of Probiotic Yogurt Compared to Xylitol

NCT ID: NCT03889015

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Geriatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The subjects will be assigned randomly into two equal groups to receive either probiotic yogurt or xylitol-containing chewing gum for three months
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
1. 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.
2. Implementation: D.K. will generate the allocation sequence, enroll participants, and assign participants to interventions.
3. Blinding: The assessors M.A. and R.E. will be blinded to the material assignment.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

xylitol chewing gum

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type EXPERIMENTAL

Probiotic yogurt

Intervention Type DIETARY_SUPPLEMENT

Probiotics are found in different dairy products including yoghurt, that are known as carriers of probiotics. These products can be easily integrated in daily meals to reduce cariogenic streptococcus mutans bacteria in dental biofilm

Interventions

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Probiotic yogurt

Probiotics are found in different dairy products including yoghurt, that are known as carriers of probiotics. These products can be easily integrated in daily meals to reduce cariogenic streptococcus mutans bacteria in dental biofilm

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hadier Mahmoud Ahmed Gad

Internal resident in conservative department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hadier Gad, masters degree

Role: CONTACT

(+202) 01067838532

faculty of dentistry, cairouniversity

Role: CONTACT

(+202) 23634965

Other Identifiers

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probiotic versus xylitol

Identifier Type: -

Identifier Source: org_study_id

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