Prevention of Recurrent Caries With Lactobacilli PRECAL

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04929340
• Other study ID #: OD5.1-8-17
• Status: Suspended
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2021
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 70
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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).
• Placebo
Children in control group are given 5 drops per day (containing no bacteria).

Locations

Country	Name	City	State
Sweden	Barntandvården Halmstad	Halmstad
Sweden	Eastmaninstitutet Pedodonti, Stockholm	Stockholm
Sweden	Tandläkarhögskolan Umeå	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dental caries	dental caries (International Caries Detection and Assesment System, ICDAS level)	6 months
Primary	dental caries	dental caries (International Caries Detection and Assesment System, ICDAS level)	12 months
Secondary	visible supra-gingival plaque	presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)	6 months
Secondary	visible supra-gingival plaque	presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)	12 months