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Effect of Xylitol on Oral Microbiota in Children

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ClinicalTrials.gov Identifier: NCT01528969
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborators:
University of Turku
University of Michigan
Information provided by (Responsible Party):
Eino Honkala, Kuwait University

Tracking Information
First Submitted Date  ICMJE January 24, 2012
First Posted Date  ICMJE February 8, 2012
Results First Submitted Date  ICMJE March 30, 2015
Results First Posted Date  ICMJE August 10, 2015
Last Update Posted Date August 10, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2012)
MS Counts of Stimulated Saliva [ Time Frame: 5 weeks ]
The MS counts are measured at the beginning and in the end of the 5 weeks intervention
Change History Complete list of historical versions of study NCT01528969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2012)
The Changes in the Counts of the 14 Other Bacterial Species [ Time Frame: 5 weeks ]
The bacterial species will be measured from stimulated saliva at the beginning and after the intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Xylitol on Oral Microbiota in Children
Official Title  ICMJE The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Infections
Intervention  ICMJE
  • 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.
    Other Names:
    • Xylitol chewing gum
    • Sorbitol chewing gum
  • 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.
    Other Name: Sorbitol chewing gum
Study Arms  ICMJE
  • Experimental: Xylitol
    A half of the subjects will be randomly allocated into xylitol group.
    Intervention: Dietary Supplement: xylitol
  • Active Comparator: Sorbitol
    About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day
    Intervention: Dietary Supplement: sorbitol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2015)
122
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2012)
80
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • high SM count

Exclusion Criteria:

  • low SM count,
  • ongoing medication
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 11 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528969
Other Study ID Numbers  ICMJE DD02/10
KU-DD02/10 ( Other Grant/Funding Number: Kuwait University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eino Honkala, Kuwait University
Study Sponsor  ICMJE Kuwait University
Collaborators  ICMJE
  • University of Turku
  • University of Michigan
Investigators  ICMJE
Principal Investigator: Eino Honkala, PhD Faculty of Dentistry, Kuwait University
PRS Account Kuwait University
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP