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Prevention of Recurrent Childhood Caries With Probiotic Supplement, a Randomized Controlled Trial
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.
Age
2 - 5 years
Sex
ALL
Healthy Volunteers
No
Barntandvården Halmstad
Halmstad, Sweden
Eastmaninstitutet Pedodonti, Stockholm
Stockholm, Sweden
Tandläkarhögskolan Umeå
Umeå, Sweden
Start Date
May 1, 2017
Primary Completion Date
December 1, 2021
Completion Date
December 1, 2021
Last Updated
June 21, 2021
70
ESTIMATED participants
Probiotic bacteria
OTHER
Placebo
OTHER
Lead Sponsor
Umeå University
NCT07009015
NCT06558955
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06372561