NCT03919838

Effect of Probiotic on Oral Health of Children

Effect of Probiotic Lactobacillus Salivarius and Cranberry on Oral Health of Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The aim of the randomized, double-blind clinical trial with placebo is to answer the clinical question , or in children with diagnosed childhood early caries the use of L.salivarius and cranberry contained in NutroPharma lozenges will reduce new carious lesions and reduce the titre of the carcinogenic bacteria Streptococcus mutans, compared to the control group in which the placebo will be administered? The main end point will be to reduce the titre of cariogenic bacteria.

Detailed description

Probiotic bacteria are used in the prevention and treatment of gastrointestinal diseases and infections, including the treatment of oral diseases. Probiotic bacteria can be found in saliva, plaque and adhering directly to the mucous membrane. They compete with cariogenic bacteria and pathogens of periodontal disease. Increased interest in probiotics means that attempts are being made to find new solutions regarding the methods of their administration. The use of probiotic bacteria brings beneficial health effects. Lactobacillus salivarius is a strain isolated from human milk. It is inactive (heat treatment) and therefore does not produce metabolites that can promote the formation of carious lesions in the mouth by lowering the mouth potential of hydrogen.

Conditions

• Oral Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	A half of the participants will be randomly allocated to the probiotics group. They will receive two probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.
DIETARY_SUPPLEMENT	Placebo - No probiotics	A half of the participants will be randomly allocated to the placebo group. They will receive two no probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.

Timeline

• Start date: 2019-07-19
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-04-18
• Last updated: 2019-10-31

Locations

1 site across 1 country: Poland