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Effect of Xylitol on Oral Microbiota in Children

NCT01528969 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2015-08-10

Study results available
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Summary

1. 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.
2. 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.
3. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use.
4. 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

xylitol

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.

DIETARY_SUPPLEMENT

sorbitol

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.

Sponsors & Collaborators

  • University of Turku

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Kuwait University

    lead OTHER

Principal Investigators

  • Eino Honkala, PhD · Faculty of Dentistry, Kuwait University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-04-30
Completion
2012-05-31

Countries

  • Kuwait

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528969 on ClinicalTrials.gov