Effect of Xylitol on Oral Microbiota in Children
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): xylitol; sorbitol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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 intervention name(s): Xylitol chewing gum; Sorbitol chewing gum; Sorbitol chewing gum
Intervention MeSH terms: Sorbitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: oral microbiota; mutans streptococci; xylitol