Prevention of Recurrent Caries With Lactobacilli PRECAL

Umeå University

Status: Suspended

Conditions: Dental Caries in Children

Treatments: Other: Placebo; Other: Probiotic bacteria

Study type: Interventional

Funder types: Other

Identifiers

NCT04929340

OD5.1-8-17

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

experimental

Experimental group

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.

Treatment:

Other: Probiotic bacteria

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo