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

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

Detailed Description
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Dietary Supplement: 2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine.
* Dietary Supplement: Placebo


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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>A lozenge containing 2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine 2% to be taken once daily | Dietary Supplement: 2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine.<br>* One lozenge once daily for 12 months<br>|
| Placebo Comparator: Placebo<br>An identical lozenge except for the absence of probiotics and arginine to be taken once daily. | Dietary Supplement: Placebo<br>* Placebo once daily for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months |