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

• ClinicalTrials.gov Identifier: NCT03928587
• Recruitment Status: Active, not recruiting
• First Posted: April 26, 2019
• Last Update Posted: February 9, 2022
• Sponsor: Chr Hansen
• Collaborator: University of Copenhagen
• Information provided by (Responsible Party): Chr Hansen

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	Not Applicable

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 (Clinical Trial)
• 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: October 8, 2021
• Estimated Study Completion Date: June 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

Outcome Measures

Primary Outcome Measures :

1. Increase in caries incidence [ Time Frame: 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

• Ages Eligible for Study: 5 Years to 8 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Denmark

University of Copenhagen

Copenhagen, Denmark

Sponsors and Collaborators

Chr Hansen

University of Copenhagen

Investigators

• Principal Investigator: Azam Bakhshandeh, PhD; University of Copenhagen

More Information

• Responsible Party: Chr Hansen
• ClinicalTrials.gov Identifier: NCT03928587
• Other Study ID Numbers: HND-IM-034
• First Posted: April 26, 2019
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases