NCT04929340

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

4.6 years

First QC Date

June 10, 2021

Last Update Submit

June 17, 2021

Conditions

Dental Caries in Children

Keywords

Early childhood cariesProbiotic bacteria

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • visible supra-gingival plaque

    6 months

  • visible supra-gingival plaque

    12 months

Study Arms (2)

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

placebo

PLACEBO COMPARATOR

5 drops each day before bedtime but after toothbrushing. The placebo drops had identical composition color and taste but no probiotic bacteria.

Other: Placebo

Interventions

Probiotic bacteriaOTHER

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).

Also known as: Experimental
experimental
PlaceboOTHER

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

placebo

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • medically comprised children
  • children with severe cognitive problems or dysfunctional families
  • families planning to relocate within the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Barntandvården Halmstad

Halmstad, 301 85, Sweden

Location

Eastmaninstitutet Pedodonti, Stockholm

Stockholm, 10231, Sweden

Location

Tandläkarhögskolan Umeå

Umeå, 901 85, Sweden

Location

Related Publications (1)

  • Hasslof P, Granqvist L, Stecksen-Blicks C, Twetman S. Prevention of Recurrent Childhood Caries with Probiotic Supplements: A Randomized Controlled Trial with a 12-Month Follow-Up. Probiotics Antimicrob Proteins. 2022 Apr;14(2):384-390. doi: 10.1007/s12602-022-09913-9. Epub 2022 Jan 26.

    PMID: 35083729DERIVED

Study Officials

  • Pamela Hasslöf

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
yellow / blue dots on the bottles indicates different groups
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, senior consultant dentist

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 18, 2021

Study Start

May 1, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(3)