Clinical trial NCT01528969: Effect of Xylitol on Oral Microbiota in Children
Official title: The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bacterial Infections
Keywords: oral microbiota
mutans streptococci
xylitol
Lead sponsor: Kuwait University
Sponsor class: OTHER
Collaborators: name: University of Turku
name: University of Michigan
First posted: 2012-02-08
Enrollment: 122
Sex: MALE
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* high SM count

Exclusion Criteria:

* low SM count,
* ongoing medication

Primary outcomes:
measure: MS Counts of Stimulated Saliva
timeFrame: 5 weeks
Secondary outcomes:
measure: The Changes in the Counts of the 14 Other Bacterial Species
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Faculty of Dentistry, Kuwait University
Study officials:
affiliation: Faculty of Dentistry, Kuwait University
name: Eino Honkala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Honkala E, Honkala S, Shyama M, Al-Mutawa SA. Field trial on caries prevention with xylitol candies among disabled school students. Caries Res. 2006;40(6):508-13. doi: 10.1159/000095650.
citation: Honkala E, Rimpela A, Karvonen S, Rimpela M. Chewing of xylitol gum--a well adopted practice among finnish adolescents. Caries Res. 1996;30(1):34-9. doi: 10.1159/000262134.