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recruitment on hold since spring 2020 due to Covid-19 pandemic
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The aim of this study was to compare the effect of drops containing probiotic bacteria (Lactobacillus reuteri 17938, Lactobacillus reuteri PTA 5289, Biogaia AB, Sweden) on the incidence of dental caries with placebo drops in preschool children undergoing comprehensive restorative treatment under general anesthesia or conscious sedation. The project will be conducted at three specialist centers (Umeå University, Umeå, Sweden, Maxillo-facial unit, Halmstad Hospital, Sweden; Eastman Institute, Stockholm, Sweden) and employ a randomized placebo-controlled design with two parallel arms. The study will be performed double-blind and neither the parents nor the clinicians will be aware of the content of the drops. The follow-up period is one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | 5 drops each day before bedtime but after toothbrushing. L. reuteri DSM 17938, L. reuteri ATCC PTA 5289, with a minimum of 100 million live bacteria of each strain. |
|
| placebo | Placebo Comparator | 5 drops each day before bedtime but after toothbrushing. The placebo drops had identical composition color and taste but no probiotic bacteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic bacteria | Other | The children are randomly allocated to a test or a control group with aid of computer-generated numbers at the time of consent. After the treatment, children in the test group are given 5 drops per day containing probiotic bacteria (Lactobacillus reuteri Protectis DSM 17938, Biogaia AB, Sweden) before bedtime. One dose consists of a minimum of 100 million live bacteria. Children in control group are given 5 drops per day (containing no bacteria). |
| Measure | Description | Time Frame |
|---|---|---|
| dental caries | dental caries (International Caries Detection and Assesment System, ICDAS level) | 6 months |
| dental caries | dental caries (International Caries Detection and Assesment System, ICDAS level) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| visible supra-gingival plaque | presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no) | 6 months |
| visible supra-gingival plaque | presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Hasslöf | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barntandvården Halmstad | Halmstad | 301 85 | Sweden | |||
| Eastmaninstitutet Pedodonti, Stockholm |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35083729 | Derived | Hasslof P, Granqvist L, Stecksen-Blicks C, Twetman S. Prevention of Recurrent Childhood Caries with Probiotic Supplements: A Randomized Controlled Trial with a 12-Month Follow-Up. Probiotics Antimicrob Proteins. 2022 Apr;14(2):384-390. doi: 10.1007/s12602-022-09913-9. Epub 2022 Jan 26. |
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yellow / blue dots on the bottles indicates different groups
|
|
| Placebo | Other | Children in control group are given 5 drops per day (containing no bacteria). |
|
| 12 months |
| Stockholm |
| 10231 |
| Sweden |
| Tandläkarhögskolan Umeå | Umeå | 901 85 | Sweden |