Prevention of Recurrent Caries With Lactobacilli PRECAL

• ClinicalTrials.gov Identifier: NCT04929340
• Recruitment Status: Suspended
• First Posted: June 18, 2021
• Last Update Posted: June 21, 2021
• Sponsor: Umeå University
• Information provided by (Responsible Party): Pamela Hasselof, Umeå University

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.

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

Study Design

• 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

Arms and Interventions

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).

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Pamela Hasslöf; Umeå University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hasslöf P, Granqvist L, Stecksén-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.

• 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
• Last Update Posted: June 21, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases