Effect of Probiotic on Oral Health of Children

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03919838
• Collaborator: NutroPharma (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.4
• Patients Per Site Per Month: 18

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Oral Disease	Dietary Supplement: Probiotics; Dietary Supplement: Placebo - No probiotics	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel AssignmentParallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Probiotic Lactobacillus Salivarius and Cranberry on Oral Health of Children
• Actual Study Start Date: Jul 19, 2019
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Probiotics Participants will receive two lozenges containing probiotic bacteria and cranberry.	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.
Placebo Comparator: Placebo - No probiotics Participants will receive a control two lozenges containing no probiotic bacteria.	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.

Outcome Measures

Primary Outcome Measures

1. Changing the titre of the carcinogenic bacteria Streptococcus mutans [8 weeks]

   During control tests saliva will be applied to the medium for identification and detailed quantification of S. mutans bacteria. After the incubation, the number of bacteria will be expressed - taking into account the degree of saliva dilution - as the number of colony-forming unit (CFU) in 1 ml of saliva.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• generally healthy children aged 3-6;

• recognized caries of early childhood, dmf> 1,

• lack of active caries and inflammation of the mouth

• colony forming unit CFU > 105 / ml Streptococcus mutans

• a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.

Exclusion Criteria:

• chronic diseases and chronically taken medicines in the past,

• planned change of residence during the year,

• age below 3 and above 6 years,

• healthy teeth, dmf = 0,

• colony forming unit CFU <105 / ml Streptococcus mutans

• Patient during antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations

• no toothpaste with fluoride

• using xylitol

• lack of written consent of parents / legal guardians for participation in research.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dorota Olczak-Kowalczyk	Warsaw	Warsaw, 18 Miodowa Saint	Poland	00-246

Sponsors and Collaborators

• Medical University of Warsaw
• NutroPharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT03919838
• Other Study ID Numbers: KB/232/2016
• First Posted: Apr 18, 2019
• Last Update Posted: Oct 31, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University of Warsaw: probiotic; oral health; children
• Additional relevant MeSH terms: Mouth Diseases

Study Results

No Results Posted as of Oct 31, 2019