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Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children — PiP-C  

Dental Caries Clinical Trial

Official title:
Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children: A Randomized, Parallel-grouped, Placebo-controlled Trial

Clinical Trial Summary

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

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03928587
Study type Interventional
Source Chr Hansen
Contact
Status Completed
Phase N/A
Start date May 1, 2019
Completion date October 8, 2021
View Details
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