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| Name | Class |
|---|---|
| West China College of Stomatology | OTHER |
| Kaunas University of Medicine | OTHER |
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The purpose of this study is to evaluate the clinical effect of chewing gum containing maltitol, on re-mineralization of early caries following daily chewing for 6 months by school children, compared to a xylitol gum, gum base and a no gum group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maltitol | Experimental |
| |
| xylitol | Active Comparator |
| |
| gum base | Placebo Comparator |
| |
| no gum | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maltitol | Other | maltitol chewing gum: 66% SweetPearlTM Maltitol +30.91% gum base+1.93% Lycasin R 85/55+0.39% glycerin; two pellets for 10 min five times each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence | baseline and 3 months | |
| Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip | baseline and 3 months | |
| Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deyu Hu, Ph.D. | West China College of Stomatology, Sichuan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China College of Stomatology, Sichuan University | Sichuan | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C010745 | maltitol |
| D014993 | Xylitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| xylitol | Other | xylitol chewing gum: 67.73% xylitol +30.02% gum base+1.13% Lycasin R 85/55+0.38% glycerin; two pellets for 10 min five times each day |
|
| gum base | Other | gum base: 99% gum base; two pellets for 10 min five times each day |
|
| Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter | baseline and 3 months |
| Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter | baseline and 6 months |
| Change from baseline in Silness & Loe Plaque index at 3 months | baseline and 3 months |
| Change from baseline in Silness & Loe Plaque index at 6 months | baseline and 6 months |