Skip to main content
Clinical Trials/NCT01528969
NCT01528969
Completed
Phase 1

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

Kuwait University1 site in 1 country122 target enrollmentMarch 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bacterial Infections
Sponsor
Kuwait University
Enrollment
122
Locations
1
Primary Endpoint
MS Counts of Stimulated Saliva
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

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: 1. How will the "normal flora" be affected by the xylitol consumption? 2. Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci? 3. 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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
May 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eino Honkala

Professor

Kuwait University

Eligibility Criteria

Inclusion Criteria

  • high SM count

Exclusion Criteria

  • low SM count,
  • ongoing medication

Outcomes

Primary Outcomes

MS Counts of Stimulated Saliva

Time Frame: 5 weeks

The MS counts were measured at the beginning and in the end of the 5 weeks intervention

Secondary Outcomes

  • The Changes in the Counts of the 14 Other Bacterial Species(5 weeks)

Study Sites (1)

Loading locations...

Similar Trials