Prevention of Recurrent Caries With Lactobacilli PRECAL

June 17, 2021 updated by: Pamela Hasselof, Umeå University

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

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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Halmstad, Sweden, 301 85
        • Barntandvården Halmstad
      • Stockholm, Sweden, 10231
        • Eastmaninstitutet Pedodonti, Stockholm
      • Umeå, Sweden, 901 85
        • Tandläkarhögskolan Umeå

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental
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
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 Names:
  • Experimental
PLACEBO_COMPARATOR: placebo
5 drops each day before bedtime but after toothbrushing. The placebo drops had identical composition color and taste but no probiotic bacteria.
Other: Placebo
Children in control group are given 5 drops per day (containing no bacteria).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Pamela Hasslöf, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (ACTUAL)

June 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OD5.1-8-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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