Effect of Xylitol on Oral Microbiota in Children
Primary Purpose
Bacterial Infections
Status
Completed
Phase
Phase 1
Locations
Kuwait
Study Type
Interventional
Intervention
xylitol
sorbitol
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Infections focused on measuring oral microbiota, mutans streptococci, xylitol
Eligibility Criteria
Inclusion Criteria:
- high SM count
Exclusion Criteria:
- low SM count,
- ongoing medication
Sites / Locations
- Faculty of Dentistry, Kuwait University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Xylitol
Sorbitol
Arm Description
A half of the subjects will be randomly allocated into xylitol group.
About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day
Outcomes
Primary Outcome Measures
MS Counts of Stimulated Saliva
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
Secondary Outcome Measures
The Changes in the Counts of the 14 Other Bacterial Species
The bacterial species were measured from stimulated saliva at the beginning and after the intervention
Full Information
NCT ID
NCT01528969
First Posted
January 24, 2012
Last Updated
July 14, 2015
Sponsor
Kuwait University
Collaborators
University of Turku, University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT01528969
Brief Title
Effect of Xylitol on Oral Microbiota in Children
Official Title
The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuwait University
Collaborators
University of Turku, University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present controlled, randomized, doubleblind study aims to answer the following questions:
How will the "normal flora" be affected by the xylitol consumption?
Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
The association of the test results will also be compared with the caries status at the baseline.
About eighty subjects with MS counts of log CFU 5 or more will be identified and invited to the study. They will be randomly divided into a Xylitol and Sorbitol group.
Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use.
Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general.
Detailed Description
Xylitol, a 5-carbon polyol, has in clinical studies prevented caries occurrence in children and decreased counts of mutans streptococci (MS) and the amount of plaque when used on daily basis. How xylitol influences mutans streptococci is far from clear. Also the effects of xylitol on the normal flora are poorly understood.
The present controlled, randomized, doubleblind study aims to answer the following questions:
How will the "normal flora" be affected by the xylitol consumption?
Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
The association of the test results will also be compared with the caries status at the baseline.
After collecting informed consent forms from the parents, about 177 children will be screened for the presence of salivary mutans streptococci (SM) with chairside test, Dentocult SM® Strip mutans (Orion Diagnostica, Finland).
Sorbitol is regarded as an inert polyol. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general. Comparison of MS counts in unstimulated vs. stimulated saliva will show how xylitol affected the adhesivity of the MS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
oral microbiota, mutans streptococci, xylitol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xylitol
Arm Type
Experimental
Arm Description
A half of the subjects will be randomly allocated into xylitol group.
Arm Title
Sorbitol
Arm Type
Active Comparator
Arm Description
About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
xylitol
Other Intervention Name(s)
Xylitol chewing gum, Sorbitol chewing gum
Intervention Description
Subjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day in the experimental group for a five-week period.
Intervention Type
Dietary Supplement
Intervention Name(s)
sorbitol
Other Intervention Name(s)
Sorbitol chewing gum
Intervention Description
Subjects will chew 2 pieces of sorbitol chewing gum (1,5 g/pellet) three times a day in the control group for a five-week period.
Primary Outcome Measure Information:
Title
MS Counts of Stimulated Saliva
Description
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
The Changes in the Counts of the 14 Other Bacterial Species
Description
The bacterial species were measured from stimulated saliva at the beginning and after the intervention
Time Frame
5 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
high SM count
Exclusion Criteria:
low SM count,
ongoing medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eino Honkala, PhD
Organizational Affiliation
Faculty of Dentistry, Kuwait University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Kuwait University
City
Kuwait
Country
Kuwait
12. IPD Sharing Statement
Citations:
PubMed Identifier
17063022
Citation
Honkala E, Honkala S, Shyama M, Al-Mutawa SA. Field trial on caries prevention with xylitol candies among disabled school students. Caries Res. 2006;40(6):508-13. doi: 10.1159/000095650.
Results Reference
background
PubMed Identifier
8850581
Citation
Honkala E, Rimpela A, Karvonen S, Rimpela M. Chewing of xylitol gum--a well adopted practice among finnish adolescents. Caries Res. 1996;30(1):34-9. doi: 10.1159/000262134.
Results Reference
background
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Effect of Xylitol on Oral Microbiota in Children
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