Effect of probiotic chewing tablets on early childhood caries – a randomized controlled trial
Authors: Trifa Hedayati-Hajikand, Ulrika Lundberg, Catarina Eldh, Svante Twetman
Journal: BMC Oral Health | Published: September 24, 2015 | DOI: 10.1186/s12903-015-0096-5 | ClinicalTrials.gov: NCT01720771
Abstract
Background: To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area.
Methods: Randomized double-blind placebo-controlled design. 138 healthy 2–3-year-old children were randomized to test or placebo group. The test group received one chewing tablet per day containing the ProBiora3® blend of three probiotic strains (S. uberis KJ2™, S. oralis KJ3™, S. rattus JH145™) for one year. Placebo group received identical tablets without probiotic bacteria.
Results: Caries increment (Δds) was significantly lower in the test group vs. placebo: 0.2 vs. 0.8 (p < 0.05). Risk reduction was 0.47 (95% CI 0.24–0.98). Number needed to treat was close to five. No side effects were reported.
Conclusions: Early childhood caries development could be reduced through daily administration of these probiotic chewing tablets as adjunct to fluoride toothpaste use in preschool children.
Study Design
Children in the test group received tablets (EvoraKids®) containing not less than 1×10⁸ total CFU of the ProBiora3® blend, sweetened with erythritol and wild cherry flavored. One tablet per day after brushing for one year. Primary outcome: caries increment. Secondary endpoints: presence of plaque and gingival health.
Key Results
| Measure | Test Group (n=54) | Placebo Group (n=56) | p value |
|---|---|---|---|
| Caries increment Δds (mean) | 0.2 | 0.8 | <0.05 |
| Caries prevalence at follow-up | 24% | 47% | <0.05 |
| Prevented fraction | 75% | ||
| Relative risk reduction | 0.47 (95% CI 0.24–0.98) | ||
No harmful events were reported. No permanent restorative treatment or extractions were carried out in any participants.
