Consumption Effect of Probiotic Products on Salivary Cariogenic Bacterial Counts in Preschool Children.
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFebruary 26, 2016
February 1, 2016
1.1 years
February 23, 2016
February 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The salivary mutans streptococci and lactobacilli counts
2 months
Secondary Outcomes (1)
Dental plaque accumulation.
2 months
Study Arms (2)
Group A
EXPERIMENTALGroup 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
PLACEBO COMPARATORGroup 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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) .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King abulaziz University, Dental University Hospital
Jeddah, P.O Box 80209, 21589, Saudi Arabia
Related Publications (7)
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.
PMID: 15286119RESULTFeatherstone 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.
PMID: 15286120RESULTLILLY 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.
PMID: 14242024RESULTAminabadi 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.
PMID: 21454978RESULTCildir 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.
PMID: 21309653RESULTSudhir 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.
PMID: 23293413RESULTJuneja 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.
PMID: 23342560RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Najlaa M Alamoudi, BDS, MS, DS
King Abdulaziz University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 23, 2016
First Posted
February 26, 2016
Study Start
January 1, 2015
Primary Completion
February 1, 2016
Study Completion
April 1, 2016
Last Updated
February 26, 2016
Record last verified: 2016-02