Prevention of Recurrent Caries With Lactobacilli PRECAL

Study Overview
=================
Brief 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.

Official Title
-----------------
Prevention of Recurrent Childhood Caries With Probiotic Supplement, a Randomized Controlled Trial

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Other: Probiotic bacteria
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>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. | Other: Probiotic bacteria<br>* 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).<br>* Other names: Experimental;|
| Placebo Comparator: placebo<br>5 drops each day before bedtime but after toothbrushing. The placebo drops had identical composition color and taste but no probiotic bacteria. | Other: Placebo<br>* Children in control group are given 5 drops per day (containing no bacteria).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotic bacteria, Early childhood caries