Effect of Xylitol on Oral Microbiota in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts

Conditions
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Bacterial Infections

Intervention / Treatment
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* Dietary Supplement: xylitol
* Dietary Supplement: sorbitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: high SM count Exclusion Criteria: low SM count, ongoing medication

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylitol<br>A half of the subjects will be randomly allocated into xylitol group. | Dietary Supplement: xylitol<br>* 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.<br>* Other names: Sorbitol chewing gum;|
| Active Comparator: Sorbitol<br>About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day | Dietary Supplement: sorbitol<br>* 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.<br>* Other names: Sorbitol chewing gum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MS Counts of Stimulated Saliva | The MS counts were measured at the beginning and in the end of the 5 weeks intervention | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral microbiota, mutans streptococci, xylitol