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| ID | Type | Description | Link |
|---|---|---|---|
| No ISRCTN or NIH grants |
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| Name | Class |
|---|---|
| Novonesis | INDUSTRY |
| Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier) | UNKNOWN |
| Plastone Oy, Konnevesi, Finland (provides the pacifiers) | UNKNOWN |
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Aims:
Main hypothesis:
The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.
Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child transmission of ms. Possibly xylitol delivered to infants could positively influence colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12 (a well known probiotic bacteria) we may be able to positively affect both gut and oral colonization, reflected in both dental and general health (solid data available on the latter aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it apparently is safe for the teeth, no clinical studies have looked at effects of its administration to infants on oral health. Our study aims to look at caries occurrence in infants who have received the xylitol + BB12 food supplement with a pacifier.
Recruiting of subjects to the study is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Sorbitol tablet |
|
| 2 | Placebo Comparator | Xylitol tablet |
|
| 3 | Active Comparator | Xylitol + BB12 tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorbitol | Dietary Supplement | Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| MS colonization | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute infectious diseases | 2 years | |
| Caries occurrence | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva M Söderling, PhD | Assoc. Prof., University of Turku | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Care Centre | Muurame and Korpilahti | 40950 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23571819 | Derived | Taipale T, Pienihakkinen K, Alanen P, Jokela J, Soderling E. Administration of Bifidobacterium animalis subsp. lactis BB-12 in early childhood: a post-trial effect on caries occurrence at four years of age. Caries Res. 2013;47(5):364-72. doi: 10.1159/000348424. Epub 2013 Apr 5. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013012 | Sorbitol |
| D014993 | Xylitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Xylitol + BB12 | Dietary Supplement | Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years |
|
|
| Xylitol | Dietary Supplement | Xylitol+BB 12 delivery with a pacifier max until 2 years |
|
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |