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Effect of Xylitol on Oral Microbiota in Children

This study is not yet open for participant recruitment.
Verified February 2012 by Kuwait University
Sponsor:
Collaborators:
University of Turku
University of Michigan
Information provided by (Responsible Party):
Eino Honkala, Kuwait University
ClinicalTrials.gov Identifier:
NCT01528969
First received: January 24, 2012
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

  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.

Condition Intervention Phase
Bacterial Infections
 Dietary Supplement: xylitol
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kuwait University:

Primary Outcome Measures:
  • MS counts of stimulated saliva [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    The MS counts are measured at the beginning and in the end of the 5 weeks intervention


Secondary Outcome Measures:
  • The changes in the counts of the 14 other bacterial species [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    The bacterial species will be measured from stimulated saliva at the beginning and after the intervention


Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xylitol
A half of the subjects will be randomly allocated into xylitol group.
 Dietary Supplement: xylitol
Subjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet)three times a day in the experimental group and sorbitol chewing gum similarly in the comparative group.
Other Names:
  • Xylitol chewing gum
  • Sorbitol chewing gum
Active Comparator: Sorbitol
About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day
 Dietary Supplement: xylitol
Subjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet)three times a day in the experimental group and sorbitol chewing gum similarly in the comparative group.
Other Names:
  • Xylitol chewing gum
  • Sorbitol chewing gum

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.

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • high SM count

Exclusion Criteria:

  • low SM count,
  • ongoing medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528969

Contacts
Contact: Eino Honkala, PhD +965-65638938 eino.honkala@hsc.edu.kw
Contact: Mohamed ElSalhy, MS alsalhy1@hotmail.com

Locations
Kuwait
Faculty of Dentistry, Kuwait University Not yet recruiting
Kuwait, Kuwait
Contact: Eino Honkala, PhD     +965-65638938     eino.honkala@hsc.edu.kw    
Contact: Sisko Honkala, PhD     +965-66499048     sisko@hsc.edu.kw    
Principal Investigator: Eino Honkala, PhD            
Sponsors and Collaborators
Kuwait University
University of Turku
University of Michigan
Investigators
Principal Investigator: Eino Honkala, PhD Faculty of Dentistry, Kuwait University
  More Information

Publications:

Responsible Party: Eino Honkala, Professor, Kuwait University
ClinicalTrials.gov Identifier: NCT01528969     History of Changes
Other Study ID Numbers: DD02/10, KU-DD02/10
Study First Received: January 24, 2012
Last Updated: February 8, 2012
Health Authority: Kuwait: Joint Committee for the Protection of Human Subjects in Research

Keywords provided by Kuwait University:
oral microbiota
mutans streptococci
xylitol

Additional relevant MeSH terms:
Bacterial Infections
Sorbitol
Cathartics
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013