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| Sponsors and Collaborators: |
University of Turku Muurame and Korpilahti Health Care Centre, Finland Chr Hansen, Denmark (provides the BB 12) Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier) Plastone Oy, Konnevesi, Finland (provides the pacifiers) |
|---|---|
| Information provided by: | University of Turku |
| ClinicalTrials.gov Identifier: | NCT00638677 |
Purpose
Aims:
Main hypothesis:
The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Caries |
Dietary Supplement: Sorbitol Dietary Supplement: Xylitol + BB12 Dietary Supplement: Xylitol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-Release Pacifier |
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Sorbitol tablet
|
Dietary Supplement: Sorbitol
Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
|
|
2: Placebo Comparator
Xylitol tablet
|
Dietary Supplement: Xylitol
Xylitol+BB 12 delivery with a pacifier max until 2 years
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3: Active Comparator
Xylitol + BB12 tablet
|
Dietary Supplement: Xylitol + BB12
Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
|
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.
Eligibility| Ages Eligible for Study: | 1 Month to 4 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Finland | |
| Health Care Centre | |
| Muurame and Korpilahti, Finland, 40950 | |
| Study Chair: | Pentti O Alanen, D.Odont | Professor, Inst. Dent. Univ. Turku |
More Information
| Responsible Party: | Inst. Dent. Univ. Turku ( Prof. Pentti Alanen ) |
| Study ID Numbers: | Pacifierstudy20/8/2003, No ISRCTN or NIH grants |
| Study First Received: | March 12, 2008 |
| Last Updated: | December 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00638677 |
| Health Authority: | Finland: Ethics Committee |
|
Tooth Diseases Sorbitol Stomatognathic Diseases Dental Caries |
|
Therapeutic Uses Gastrointestinal Agents Cathartics Pharmacologic Actions Tooth Demineralization |
