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Prevention of Recurrent Caries With Lactobacilli PRECAL

Primary Purpose

Dental Caries in Children

Status
Suspended
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotic bacteria
Placebo
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring Early childhood caries, Probiotic bacteria

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barntandvården Halmstad
  • Eastmaninstitutet Pedodonti, Stockholm
  • Tandläkarhögskolan Umeå

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental

placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

dental caries
dental caries (International Caries Detection and Assesment System, ICDAS level)
dental caries
dental caries (International Caries Detection and Assesment System, ICDAS level)

Secondary Outcome Measures

visible supra-gingival plaque
presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)
visible supra-gingival plaque
presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)

Full Information

First Posted
June 10, 2021
Last Updated
June 17, 2021
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT04929340
Brief Title
Prevention of Recurrent Caries With Lactobacilli PRECAL
Official Title
Prevention of Recurrent Childhood Caries With Probiotic Supplement, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Suspended
Why Stopped
recruitment on hold since spring 2020 due to Covid-19 pandemic
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
Early childhood caries, Probiotic bacteria

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
yellow / blue dots on the bottles indicates different groups
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
5 drops each day before bedtime but after toothbrushing. The placebo drops had identical composition color and taste but no probiotic bacteria.
Intervention Type
Other
Intervention Name(s)
Probiotic bacteria
Other Intervention Name(s)
Experimental
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Children in control group are given 5 drops per day (containing no bacteria).
Primary Outcome Measure Information:
Title
dental caries
Description
dental caries (International Caries Detection and Assesment System, ICDAS level)
Time Frame
6 months
Title
dental caries
Description
dental caries (International Caries Detection and Assesment System, ICDAS level)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
visible supra-gingival plaque
Description
presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)
Time Frame
6 months
Title
visible supra-gingival plaque
Description
presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Hasslöf
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barntandvården Halmstad
City
Halmstad
ZIP/Postal Code
301 85
Country
Sweden
Facility Name
Eastmaninstitutet Pedodonti, Stockholm
City
Stockholm
ZIP/Postal Code
10231
Country
Sweden
Facility Name
Tandläkarhögskolan Umeå
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35083729
Citation
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.
Results Reference
derived

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Prevention of Recurrent Caries With Lactobacilli PRECAL

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