Bacterial Infections
Conditions
Keywords
oral microbiota, mutans streptococci, xylitol
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.
Interventions
DIETARY_SUPPLEMENTxylitol
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.
DIETARY_SUPPLEMENTsorbitol
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.
Sponsors
University of Turku
University of Michigan
Kuwait University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
11 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* high SM count
Exclusion criteria
* low SM count, * ongoing medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MS Counts of Stimulated Saliva | 5 weeks | The MS counts were measured at the beginning and in the end of the 5 weeks intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Changes in the Counts of the 14 Other Bacterial Species | 5 weeks | The bacterial species were measured from stimulated saliva at the beginning and after the intervention |
Countries
Kuwait
Participant flow
Recruitment details
Altogether 122 10-12-year-old boys, whose parents gave a positive consent, participated in the baseline examinations. The study was conducted at one school in Jabriya, Kuwait.
Pre-assignment details
Str mutans was measured from plaque and saliva. Those children who had high mutans counts (n=75) were included into the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Xylitol A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w. | 37 |
| Sorbitol A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%. | 38 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | absent from the school at baseline | 2 | 0 |
Baseline characteristics
| Characteristic | Xylitol | Sorbitol | Total |
|---|---|---|---|
| Age, Continuous | 11.5 years | 11.5 years | 11.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 38 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Nationality of subjects Kuwaiti | 36 participants | 37 participants | 73 participants |
| Nationality of subjects non-Kuwaiti Arab | 1 participants | 1 participants | 2 participants |
| Region of Enrollment Kuwait | 37 participants | 38 participants | 75 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 37 Participants | 38 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 38 |
| serious Total, serious adverse events | 0 / 35 | 0 / 38 |
Outcome results
Primary
MS Counts of Stimulated Saliva
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
Time frame: 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Xylitol | MS Counts of Stimulated Saliva | Baseline | 4.86 MS counts log CFU/ml | Standard Deviation 1.34 |
| Xylitol | MS Counts of Stimulated Saliva | 5-week follow-up | 4.29 MS counts log CFU/ml | Standard Deviation 1.73 |
| Sorbitol | MS Counts of Stimulated Saliva | Baseline | 4.40 MS counts log CFU/ml | Standard Deviation 1.71 |
| Sorbitol | MS Counts of Stimulated Saliva | 5-week follow-up | 3.78 MS counts log CFU/ml | Standard Deviation 1.83 |
Secondary
The Changes in the Counts of the 14 Other Bacterial Species
The bacterial species were measured from stimulated saliva at the beginning and after the intervention
Time frame: 5 weeks