Prevention of Recurrent Caries With Lactobacilli PRECAL

Not Applicable

Suspended

• Conditions: Dental Caries in Children
• Interventions: Other: Placebo; Other: Probiotic bacteria

• Registration Number: NCT04929340
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-21
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	5 drops each day before bedtime but after toothbrushing. The placebo drops had identical composition color and taste but no probiotic bacteria.
experimental	Probiotic bacteria	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.

Primary Outcome Measures

Name	Time	Method
dental caries	12 months	dental caries (International Caries Detection and Assesment System, ICDAS level)

Secondary Outcome Measures

Name	Time	Method
visible supra-gingival plaque	12 months	presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)

Trial Locations

Locations (3)

Eastmaninstitutet Pedodonti, Stockholm; 🇸🇪 Stockholm, Sweden

Barntandvården Halmstad; 🇸🇪 Halmstad, Sweden

Tandläkarhögskolan Umeå; 🇸🇪 Umeå, Sweden