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

Dental Caries Clinical Trial

— PiP-C  

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 Details — Status: Completed

Administrative data

• NCT number: NCT03928587
• Other study ID #: HND-IM-034
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 8, 2021

Study information

• Verified date: September 2022
• Source: Chr Hansen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Dietary Supplement:
• 2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine.
One lozenge once daily for 12 months
• Placebo
Placebo once daily for 12 months

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Chr Hansen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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