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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04929340
Other study ID # OD5.1-8-17
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date December 1, 2021

Study information

Verified date June 2021
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Suspended
Enrollment 70
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 5 Years
Eligibility Inclusion Criteria: - Preschool children, 2-5 year of age - with Early childhood caries (ECC) or - severe Early childhood caries (S-ECC) - scheduled for restorations and extractions under general anesthesia or any form of sedation - The obligate requirement is that the child should be fully treated and managed with aspect to caries within a period of not more than two months. Exclusion Criteria: - medically comprised children - children with severe cognitive problems or dysfunctional families - families planning to relocate within the next year

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Probiotic bacteria
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).
Placebo
Children in control group are given 5 drops per day (containing no bacteria).

Locations

Country Name City State
Sweden Barntandvården Halmstad Halmstad
Sweden Eastmaninstitutet Pedodonti, Stockholm Stockholm
Sweden Tandläkarhögskolan Umeå Umeå

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary dental caries dental caries (International Caries Detection and Assesment System, ICDAS level) 6 months
Primary dental caries dental caries (International Caries Detection and Assesment System, ICDAS level) 12 months
Secondary visible supra-gingival plaque presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no) 6 months
Secondary visible supra-gingival plaque presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no) 12 months
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