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Prevention of Recurrent Caries With Lactobacilli PRECAL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04929340
Recruitment Status : Suspended (recruitment on hold since spring 2020 due to Covid-19 pandemic)
First Posted : June 18, 2021
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pamela Hasselof, 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.

Condition or disease Intervention/treatment Phase
Dental Caries in Children Other: Probiotic bacteria Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: yellow / blue dots on the bottles indicates different groups
Primary Purpose: Prevention
Official Title: Prevention of Recurrent Childhood Caries With Probiotic Supplement, a Randomized Controlled Trial
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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 Name: 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).




Primary Outcome Measures :
  1. dental caries [ Time Frame: 6 months ]
    dental caries (International Caries Detection and Assesment System, ICDAS level)

  2. dental caries [ Time Frame: 12 months ]
    dental caries (International Caries Detection and Assesment System, ICDAS level)


Secondary Outcome Measures :
  1. visible supra-gingival plaque [ Time Frame: 6 months ]
    presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)

  2. visible supra-gingival plaque [ Time Frame: 12 months ]
    presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04929340


Locations
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Sweden
Barntandvården Halmstad
Halmstad, Sweden, 301 85
Eastmaninstitutet Pedodonti, Stockholm
Stockholm, Sweden, 10231
Tandläkarhögskolan Umeå
Umeå, Sweden, 901 85
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Pamela Hasslöf Umeå University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pamela Hasselof, Principal Investigator, senior consultant dentist, Umeå University
ClinicalTrials.gov Identifier: NCT04929340    
Other Study ID Numbers: OD5.1-8-17
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pamela Hasselof, Umeå University:
Early childhood caries
Probiotic bacteria
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases