Consumption Effect of Probiotic Products on Salivary Cariogenic Bacterial Counts in Preschool Children.

February 23, 2016 updated by: Najlaa Alamoudi, King Abdulaziz University
The purpose of this study is to evaluate the efficacy of probiotic products on caries-associated salivary bacterial counts (Streptococcus mutans and Lactobacillus) and its effect on dental plaque accumulation in a group of preschool children in Saudi Arabia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Among the dental conditions that are most common among the children is dental caries. This condition can afflict an individual in the course of their entire life. However, it is possible to develop prevention mechanisms especially during childhood (1). Dental caries can be defined as the damage of a specific susceptible part of the enamel through acids that are produced by bacteria as they ferment carbohydrates that have been trapped within the teeth (2). A number of endogenous bacteria are known of producing acidic by-products, which ends up destroying the tooth. Some of the notorious bacteria are Streptococci mutans, Lactobacillus spp. and Streptococcus sobrinus. Release of acids through fermentation cause a fall in pH causing decalcifying of the structure of enamel, thereby causing irreversible damage in form of caries (3, 4). Recent research studies have indicated that the use of probiotics provides a future prevention solution against caries. The use of probiotic therapy is based on the fact that the oral cavity has a specific ecosystem of bacteria comprising of normal flora and pathogenic bacteria, which live together. Probiotic therapy seeks to balance this oral ecosystem so as to ensure that harmful bacteria are eliminated. An imbalance in oral ecosystem can cause dental caries, for example, streptococcus mutans, which form part of the normal oral flora can result to decalcification of the enamel if their numbers rise beyond normal. Probiotic is a derivative of Greek work, which means "for life," it was first used in 1965 by Lilly and Stillwell and was found to be a contrast of the antibiotic (5). WHO/FAO (2002) defines probiotics as living organisms that have health benefits to the host when administered in the desirable amounts. In a number of studies on probiotics, the focus has been on reducing the number of mutans streptococci. The most widely used probiotic strains are Lactobacillus and Bifidobacterium. Irrespective of the strain or product used, various studies point to reduced number of mutans streptococci in saliva, an effect that is widely varied with the study groups being small (6,7,8,9) and conducted over a short period (6,7,8,9,10). Based on these findings, the efficacy of probiotic chewable tablets in prevention of caries require further analysis.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • P.O Box 80209
      • Jeddah, P.O Box 80209, Saudi Arabia, 21589
        • Recruiting
        • King abulaziz University, Dental University Hospital
        • Contact:
        • Principal Investigator:
          • Najla M Alamoudi, Dsc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy children having no history of any systemic conation, having full set of primary dentition, having high counts of salivary mutants streptococci ( ≥ 105 CFU ), dft score ≥ 3, with no history of recent antibiotics administration (At least one month prior to the intervention) .

Exclusion Criteria:

  • Disapproved consent, medically compromised children, children using topical fluoride within the 4 weeks prior to baseline except the fluoride in the toothpaste, and children using xylitol chewing gums.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A

Group A (test group): This group consist of 80 children receiving the probiotic lozenges.

The Probiotic lozenges used in the trial is a non-commercial product provided by BioGaia AB, Lund, Sweden. The Probiotic lozenges consist of a minimum of 200 million live L. reuteri (L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289 (L. reuteri Prodentis®). The probiotic lozenge is used twice daily for two months.
Dietary supplement: (L. reuteri Prodentis®).
The Test group is instructed to consume Probiotic lozenges for two months. The counts of salivary mutans streptococci and lactobacilli were evaluated using the CRT test at baseline, one-month, and two- months, from the beginning of the trial for every participating child.
PLACEBO_COMPARATOR: Group B

Group B (control group): This group consist of 80 children receiving the placebo lozenges.

The placebo lozenges used in the trial is non-commercial product provided by BioGaia AB, Lund, Sweden.The placebo lozenges is used twice daily for two months.
Dietary supplement: Placebo lozenges
The control group is instructed to consume placebo lozenges for two months. The counts of salivary mutans streptococci and lactobacilli were evaluated using the CRT test at baseline, one-month, and two- months, from the beginning of the trial for every

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The salivary mutans streptococci and lactobacilli counts
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Dental plaque accumulation.
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Investigators

  • Principal Investigator: Najlaa M Alamoudi, BDS, MS, DS, King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

February 1, 2016

Study Completion (ANTICIPATED)

April 1, 2016

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (ESTIMATE)

February 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAUFD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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