Antibacterial Effect of Probiotic Yogurt Compared to Xylitol

NCT03889015 | Unknown

• 1 other identifier: probiotic versus xylitol
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Geriatric Patients

Outcome Measures

Primary Outcomes (1)

• streptococcus mutans count in saliva

  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

  3 months

Secondary Outcomes (3)

• streptococcus mutans count in plaque

  3 months

• salivary pH

  3 months

• bacterial adherence

  3 months

Study Arms (2)

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

Dietary Supplement: xylitol chewing gum

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

Dietary Supplement: Probiotic yogurt

Interventions

Probiotic yogurt 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

probiotic yogurt

xylitol chewing gum 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

xylitol chewing gum

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Hadier Gad, masters degree

CONTACT

(+202) 01067838532; hadier.mahmoud@gmail.com

faculty of dentistry, cairouniversity

CONTACT

(+202) 23634965; dentmail@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal resident in conservative department

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

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 25, 2019
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 26, 2019

Record last verified: 2019-03