Prevention of Recurrent Caries With Lactobacilli PRECAL

Umeå University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Dental Caries in Children

Interventions

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).

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (3)

Barntandvården Halmstad

Halmstad, Sweden

Eastmaninstitutet Pedodonti, Stockholm

Stockholm, Sweden

Tandläkarhögskolan Umeå

Umeå, Sweden

Outcomes

Primary Outcomes

dental caries

dental caries (International Caries Detection and Assesment System, ICDAS level)

Time frame: 6 months

dental caries

dental caries (International Caries Detection and Assesment System, ICDAS level)

Time frame: 12 months

Secondary Outcomes

visible supra-gingival plaque

presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)

Time frame: 6 months

visible supra-gingival plaque

presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)

Time frame: 12 months