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| ID | Type | Description | Link |
|---|---|---|---|
| KU-DD02/10 | Other Grant/Funding Number | Kuwait University |
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| Name | Class |
|---|---|
| University of Turku | OTHER |
| University of Michigan | OTHER |
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The present controlled, randomized, doubleblind study aims to answer the following questions:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylitol | Experimental | A half of the subjects will be randomly allocated into xylitol group. |
|
| Sorbitol | Active Comparator | About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xylitol | Dietary Supplement | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MS Counts of Stimulated Saliva | The MS counts were measured at the beginning and in the end of the 5 weeks intervention | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eino Honkala, PhD | Faculty of Dentistry, Kuwait University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Kuwait University | Kuwait City | Kuwait |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17063022 | Background | 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. | |
| 8850581 | Background | 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. |
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Str mutans was measured from plaque and saliva. Those children who had high mutans counts (n=75) were included into the intervention.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sorbitol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MS Counts of Stimulated Saliva | The MS counts were measured at the beginning and in the end of the 5 weeks intervention | Posted | Mean | Standard Deviation | MS counts log CFU/ml | 5 weeks |
|
during the 1st week after the intervention was concluded.
Subjects were interviewed about the possible side-effects (e.g. diarrhea) after the five-weeks intervention in the connection of the follow-up examinations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. None of the subjects had any adverse effects of the consumption of the chewing gum. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Interview after the intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Eino Honkala | Kuwait University, Faculty of Dentistry | +965 65638938 | eino.honkala@hsc.edu.kw |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014993 | Xylitol |
| D013012 | Sorbitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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|
| sorbitol | Dietary Supplement | 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. |
|
|
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%. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Nationality of subjects | Number | participants |
|
|
|
| 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 | Not Posted | 5 weeks |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | 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%. None of the subjects had any adverse effects of the consumption of the chewing gum. | 0 | 38 | 0 | 38 |
|
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