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

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
(L. reuteri Prodentis®).
Placebo lozenges
Sponsored by
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • King abulaziz University, Dental University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The salivary mutans streptococci and lactobacilli counts

Secondary Outcome Measures

Dental plaque accumulation.

Full Information

First Posted
February 23, 2016
Last Updated
February 23, 2016
Sponsor
King Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT02692625
Brief Title
Consumption Effect of Probiotic Products on Salivary Cariogenic Bacterial Counts in Preschool Children.
Official Title
Consumption Effect of Probiotic Products on Salivary Cariogenic Bacterial Counts in Preschool Children.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
(L. reuteri Prodentis®).
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo lozenges
Intervention Description
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
Primary Outcome Measure Information:
Title
The salivary mutans streptococci and lactobacilli counts
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Dental plaque accumulation.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Najlaa M Alamoudi, BDS, MS, DS
Phone
+966 2 6401000
Ext
20388
Email
nalamoudi2011@kau.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najlaa M Alamoudi, BDS, MS, DS
Organizational Affiliation
King Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King abulaziz University, Dental University Hospital
City
Jeddah
State/Province
P.O Box 80209
ZIP/Postal Code
21589
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najlaa M Alamoudi, DSc
Phone
6400000
Ext
20388
Email
nalamoudi@kau.edu.sa
First Name & Middle Initial & Last Name & Degree
Najla M Alamoudi, Dsc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15286119
Citation
Kidd EA, Fejerskov O. What constitutes dental caries? Histopathology of carious enamel and dentin related to the action of cariogenic biofilms. J Dent Res. 2004;83 Spec No C:C35-8. doi: 10.1177/154405910408301s07.
Results Reference
result
PubMed Identifier
15286120
Citation
Featherstone JD. The continuum of dental caries--evidence for a dynamic disease process. J Dent Res. 2004;83 Spec No C:C39-42. doi: 10.1177/154405910408301s08.
Results Reference
result
PubMed Identifier
14242024
Citation
LILLY DM, STILLWELL RH. PROBIOTICS: GROWTH-PROMOTING FACTORS PRODUCED BY MICROORGANISMS. Science. 1965 Feb 12;147(3659):747-8. doi: 10.1126/science.147.3659.747.
Results Reference
result
PubMed Identifier
21454978
Citation
Aminabadi NA, Erfanparast L, Ebrahimi A, Oskouei SG. Effect of chlorhexidine pretreatment on the stability of salivary lactobacilli probiotic in six- to twelve-year-old children: a randomized controlled trial. Caries Res. 2011;45(2):148-54. doi: 10.1159/000325741. Epub 2011 Mar 31.
Results Reference
result
PubMed Identifier
21309653
Citation
Cildir SK, Sandalli N, Nazli S, Alp F, Caglar E. A novel delivery system of probiotic drop and its effect on dental caries risk factors in cleft lip/palate children. Cleft Palate Craniofac J. 2012 May;49(3):369-72. doi: 10.1597/10-035. Epub 2011 Feb 10.
Results Reference
result
PubMed Identifier
23293413
Citation
Sudhir R, Praveen P, Anantharaj A, Venkataraghavan K. Assessment of the effect of probiotic curd consumption on salivary pH and streptococcus mutans counts. Niger Med J. 2012 Jul;53(3):135-9. doi: 10.4103/0300-1652.104382.
Results Reference
result
PubMed Identifier
23342560
Citation
Juneja A, Kakade A. Evaluating the effect of probiotic containing milk on salivary mutans streptococci levels. J Clin Pediatr Dent. 2012 Fall;37(1):9-14. doi: 10.17796/jcpd.37.1.tq91178m7w876644.
Results Reference
result

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

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