The Effect of Probiotic Lactobacillus Reuteri Prodentis Consumption on Gingival Crevicular Fluid Inflammatory Response and Metagenomic Profiles of Oral Microbiome in Orthodontic Patients.

Summary

In this study, researchers will test the effectiveness of probiotic consumption against oral pathogenic bacteria and reduce the occurrence of gingival inflammation in subjects using orthodontic fixed appliances (braces).

Lactobacillus reuteri is one of the probiotic bacteria that has been identified for its health benefits. L. reuteri produces antimicrobial substances, reuterin and reutericyclin which are active against wide range of pathogenic organisms. Previously, investigator performed a pilot study on the beneficial health effect of probiotic L. reuteri containing lozenges on a few orthodontic patients and it was proven that taking this probiotic for two weeks could significantly reduce the number of pathogenic bacteria in the patients' saliva. In vitro study showed that L. reuteri has the ability to modulate the inflammatory response such as TNF alpha and interleukins. However, The ability of L. reuteri in modulating the inflammatory response viz. Interleukin 1-beta, Interleukin 6, interleukin 8, interleukin 10, TNF alpha, MMP-9 and RANKL and effect on oral metagenomic microbiome profile in patients undergoing orthodontic treatment has not been previously investigated.

Objective:

1. To evaluate the effect of consumption of L. reuteri Prodentis probiotic lozenges on the inflammatory response (inflammation) of gingival fluid.
2. To evaluate the effect of consumption of the probiotic lozenges of L. reuteri Prodentis against oral pathogens in dental plaque and saliva.

Research Benefits:

This study was conducted to observe the effectiveness of L. reuteri (ProDentis) probiotic against oral pathogenic bacteria on patients using orthodontic fixed appliance, to reduce gum inflammation and improve oral health.

Conditions

• Healthy Subjects With Fixed Orthodontics

Interventions

DIETARY_SUPPLEMENT

BioGaia Probiotic Lozenges

BioGaia Prodentis lozenges is a food supplement for oral health that contains patented lactic acid bacteria Limosilactobacillus reuteri (formerly known as Lactobacillus reuteri) Prodentis (a combination of strains of L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289) which helps good microorganisms maintain natural balance in the mouth. This product is safe for daily use and this product can be used during pregnancy and breastfeeding. The ingredients of this product are: bulking agent (isomalt), L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289, fully hydrogenated palm oil, peppermint flavoring, menthol flavoring, peppermint oil and sweetener (sucralose). One candy contains a minimum of 200 million live L. reuteri Prodentis. Net weight per candy is 800 mg. Excessive consumption can have a laxative effect due to the sweetener content in the product. This product has obtained a distribution permit in Indonesia with a BPOM number: SI194510521 with the name Probiotic Prodentis (Pro-D).

Sponsors & Collaborators

• Duke-NUS Graduate Medical School

  collaborator OTHER

• Indonesia University

  collaborator OTHER

• BioGaia AB

  collaborator INDUSTRY

• Trisakti University

  lead OTHER

Principal Investigators

• Armelia Sari Widyarman, Ph.D · Trisakti University

• Chaminda Jayampath Seneviratne, Ph.D · Duke-NUS Graduate Medical School

• Citra Fragnantia Theodora, Ph.D · Indonesia University

• Joko Kusnoto, Sp.Ortho · Trisakti University

• Tri Erri Astoeti, Professor · Trisakti University

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

28 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-22

Primary Completion

2023-01-31

Completion

2023-03-31

Countries

• Indonesia

Study Locations