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Completed

NCT Number: NCT01528969

Effect of Xylitol on Oral Microbiota in Children

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

11 year–14 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of Dentistry, Kuwait University

Kuwait City, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • high SM count

Exclusion criteria

  • low SM count,
  • ongoing medication

Treatment and study plan

Xylitol

Dietary Supplement

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.

Other names: Xylitol chewing gum, Sorbitol chewing gum

Sorbitol

Dietary Supplement

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.

Other names: Sorbitol chewing gum

Primary outcomes

  1. 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

  1. The Changes in the Counts of the 14 Other Bacterial Species

    Time frame: 5 weeks

    The bacterial species were measured from stimulated saliva at the beginning and after the intervention

Sponsors and collaborators

Lead sponsor

Kuwait University

Other

Collaborators

  • University of Michigan
  • University of Turku

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2012
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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