The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kuwait University
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- MS Counts of Stimulated Saliva
Study Overview
Brief Summary
- 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.
- 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.
- 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.
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 11 Years to 14 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •high SM count
Exclusion Criteria
- •low SM count,
- •ongoing medication
Arms & Interventions
Sorbitol
About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day
Intervention: sorbitol (Dietary Supplement)
Xylitol
A half of the subjects will be randomly allocated into xylitol group.
Intervention: xylitol (Dietary Supplement)
Outcomes
Primary Outcomes
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
- The Changes in the Counts of the 14 Other Bacterial Species(5 weeks)
Investigators
Eino Honkala
Professor
Kuwait University