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

Sponsor

Chr Hansen (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03928587

Collaborator

University of Copenhagen (Other)

343

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Dietary Supplement: 2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine. Dietary Supplement: Placebo	N/A

Detailed 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

Study Type:

Interventional

Actual Enrollment :

343 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

Oct 8, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active 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. One lozenge once daily for 12 months
Placebo Comparator: Placebo An identical lozenge except for the absence of probiotics and arginine to be taken once daily.	Dietary Supplement: Placebo Placebo once daily for 12 months

Arm

Intervention/Treatment

Experimental: Active

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.

One lozenge once daily for 12 months

Placebo Comparator: Placebo

An identical lozenge except for the absence of probiotics and arginine to be taken once daily.

Dietary Supplement: Placebo

Placebo once daily for 12 months

Outcome Measures

Primary Outcome Measures

Increase in caries incidence [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Copenhagen	Copenhagen		Denmark

Sponsors and Collaborators

Chr Hansen
University of Copenhagen

Investigators

Principal Investigator: Azam Bakhshandeh, PhD, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chr Hansen

ClinicalTrials.gov Identifier:

NCT03928587

Other Study ID Numbers:

HND-IM-034

First Posted:

Apr 26, 2019

Last Update Posted:

Feb 9, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Feb 9, 2022