NCT04929340

Prevention of Recurrent Caries With Lactobacilli PRECAL

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
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).
OTHER	Placebo	Children in control group are given 5 drops per day (containing no bacteria).

Timeline

• Start date: 2017-05-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-06-18
• Last updated: 2021-06-21

Locations

3 sites across 1 country: Sweden