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

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ClinicalTrials.gov Identifier: NCT03928587
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Chr Hansen

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928587


Contacts
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Contact: Mette Keller, PhD 00453025853 dkmeke@chr-hansen.com

Sponsors and Collaborators
Chr Hansen
University of Copenhagen

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Responsible Party: Chr Hansen
ClinicalTrials.gov Identifier: NCT03928587     History of Changes
Other Study ID Numbers: HND-IM-034
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases