SuspendedNot Applicable

Prevention of Recurrent Caries With Lactobacilli PRECAL

Stopped: recruitment on hold since spring 2020 due to Covid-19 pandemic

Sweden70 participantsStarted 2017-05-01

Plain-language 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.

Who can participate

Age range2 Years – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

dental caries

Timeframe: 6 months

dental caries

Timeframe: 12 months

Trial details

NCT IDNCT04929340

SponsorUmeå University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Dental Caries in Children trials