Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children

Chr Hansen343 enrolled

Overview

The primary objective of this trial is to investigate the effect of a symbiotic lozenge on dental caries in young children.

The study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group study in healthy children aged 5-8 years. The objective is to investigate the effect of a symbiotic lozenge on caries increment in primary molar teeth, primary canines and erupted occlusal surfaces at the first permanent molar teeth.The study will take place in Helsingør and Fredensborg municipality. The study consists of a baseline visit prior to a 12 months intervention period, followed by a visit after completion. During the intervention period, two to four months after the baseline visit, a saliva sample will be collected. All guardians to the subjects are encouraged to 1) brush their children's teeth twice daily with the fluoride toothpaste provided, 2) avoid the food provided in appendix D and 3) to continue the subject's dental appointments at local Public Dental Health Service (PDHS). No further specific oral hygiene or dietary instructions/restrictions are provided. Assuming a dropout rate of 12.5%, 175 children will be included in each treatment group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

343

Conditions

Dental Caries

Interventions

2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine.DIETARY_SUPPLEMENT

One lozenge once daily for 12 months

PlaceboDIETARY_SUPPLEMENT

Placebo once daily for 12 months

Eligibility

Sex: ALLMin age: 5 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy children with absence of severe chronic disease 2. Age 5-8 years, both inclusive, at inclusion 3. Ability to cooperate at dental examination 4. Ability to cooperate to a daily intake of a lozenge 5. Parents/legal guarding provided voluntary written informed consent Exclusion Criteria: 1. Children with severe medical conditions 2. Mentally or physically disabled children 3. Children of parents with language barriers and not able to give written informed consent

Locations (1)

University of Copenhagen

Copenhagen, Denmark

Outcomes

Primary Outcomes

Increase in caries incidence

Caries increment in primary molar teeth, primary canines and erupted occlusal surfaces at the first permanent molar teeth in children aged 5-8 years, using a modified dmf-s scale, including the occlusal surfaces of the first permanent teeth where d is defined by ICDAS scale and assessed both clinically and by dental x-ray.

Time frame: 12 months

Data from ClinicalTrials.gov

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