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

Summary

Participation Requirements

Description

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 ...

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.

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