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

NCT03928587 | Completed

• 1 other identifier: HND-IM-034
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active

EXPERIMENTAL

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.

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine. DIETARY_SUPPLEMENT

One lozenge once daily for 12 months

Active

Placebo DIETARY_SUPPLEMENT

Placebo once daily for 12 months

Placebo

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children with absence of severe chronic disease
• Ability to cooperate at dental examination
• Ability to cooperate to a daily intake of a lozenge
• Parents/legal guarding provided voluntary written informed consent

You may not qualify if:

• Children with severe medical conditions
• Mentally or physically disabled children
• Children of parents with language barriers and not able to give written informed consent

Sponsors & Collaborators

• Chr Hansen: lead
• University of Copenhagen: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, Denmark

Location

Related Publications (2)

• Porksen CJ, Ekstrand KR, Markvart M, Larsen T, Garrido LE, Bakhshandeh A. The efficacy of combined arginine and probiotics as an add-on to 1450 ppm fluoride toothpaste to prevent and control dental caries in children - A randomized controlled trial. J Dent. 2023 Oct;137:104670. doi: 10.1016/j.jdent.2023.104670. Epub 2023 Aug 20.

  PMID: 37604396 DERIVED

• Porksen CJ, Keller MK, Damholt A, Frederiksen AKS, Ekstrand KR, Markvart M, Larsen T, Bakhshandeh A. The effect of a lozenge combining prebiotic arginine and probiotics on caries increment in children during 10-12 months, a randomized clinical trial. J Dent. 2023 Aug;135:104599. doi: 10.1016/j.jdent.2023.104599. Epub 2023 Jun 24.

  PMID: 37356561 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Arginine

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Azam Bakhshandeh, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 26, 2019
• Study Start: May 1, 2019
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)