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Clinical Trials/NCT03889015
NCT03889015UnknownNot Applicable

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

Cairo University0 sites96 target enrollmentStarted: June 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
96
Primary Endpoint
streptococcus mutans count in saliva

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

  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.

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

xylitol chewing gum

Active Comparator

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: xylitol chewing gum (Dietary Supplement)

probiotic yogurt

Experimental

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

Intervention: Probiotic yogurt (Dietary Supplement)

Outcomes

Primary Outcomes

streptococcus mutans count in saliva

Time Frame: 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 Outcomes

  • streptococcus mutans count in plaque(3 months)
  • salivary pH(3 months)
  • bacterial adherence(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hadier Mahmoud Ahmed Gad

Internal resident in conservative department

Cairo University

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