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

NCT04847960 | Unknown DMC

• 1 other identifier: 0191
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects With Fixed Orthodontics

Keywords

probiotics; Lactobacillus reuterii; oral microbiome; fixed orthodontics

Outcome Measures

Primary Outcomes (4)

• Metagenomic microbiome profile comparison between Pre- and Post-treatment described using Alpha Diversity analysis.

  Using next-generation sequencing to acquire both bacterial and fungal metagenomic profile from plaque, gingival crevicular fluid, and saliva samples, whilst comparing both profile between pre-treatment and post-treatment. The data will be analysed and presented after observed operational taxonomic units (OTU), Shannon's richness, Chao's richness, and Simpson's evenness analysis has been done.

  8 weeks

• Bacterial gene expression profile from dental plaque comparison between Pre- and Post-treatment described using relative quantification of fold gene expression (2-∆∆Ct).

  Using RT-PCR to acquire the gene expression of bacterial dental plaque that are acquired from both pre-treatment and post-treatment samples, therefore comparing bacterial dental plaque's gene expression between pre-treatment and post-treatment.

  16 weeks

• Proteomic profile assessed from gingival crevicular fluid and comparing its results between Pre- and Post-treatment as assessed using enzyme-linked immunosorbant assay.

  Using enzyme-linked immunosorbant assay to assess inflammatory responses and comparing it between pre-treatment samples and post-treatment samples. Standard curves for each marker will also be conducted. Final protein concentrations of each marker will be generated after the sample's absorbance value detected is converted using the standard curve of each marker.

  12 weeks

• OHI status and Plaque index as assessed by the dental general practitioners.

  Assessment done by dentists to analyze oral health comparisons between pre-treatment and post-treatment

  2 weeks

Study Arms (1)

L.reuterii probiotic lozenges from BioGaia

EXPERIMENTAL

Subjects were willing to provide 2 samples of saliva, dental plaque and gingival fluid (gum fluid), on the first day (before consuming lozenges) and on the 14th day after the subject consumed lozenges containing L. reuteri probiotic. Probiotics are taken once a day for two weeks after breakfast and brushing their teeth.

Dietary Supplement: BioGaia Probiotic Lozenges

Interventions

BioGaia Probiotic Lozenges DIETARY_SUPPLEMENT

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).

L.reuterii probiotic lozenges from BioGaia

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old (M/F)
• Using orthodontic fixed appliance for at least 1 year
• Do not consume probiotics and antibiotics (at least 3 months before)
• No history of systemic disease

You may not qualify if:

• Subjects with systemic diseases
• Allergic to probiotics

Sponsors & Collaborators

• Trisakti University: lead
• Duke-NUS Graduate Medical School: collaborator
• Indonesia University: collaborator
• BioGaia AB: collaborator

Study Sites (1)

Trisakti University

Jakarta, DKI Jakarta, 11440, Indonesia

Location

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Study Officials

• Armelia Sari Widyarman, Ph.D

  Trisakti University

  PRINCIPAL INVESTIGATOR

• Chaminda Jayampath Seneviratne, Ph.D

  Duke-NUS Graduate Medical School

  STUDY DIRECTOR

• Citra Fragnantia Theodora, Ph.D

  Indonesia University

  STUDY CHAIR

• Joko Kusnoto, Sp.Ortho

  Trisakti University

  STUDY CHAIR

• Tri Erri Astoeti, Professor

  Trisakti University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label trial of BioGaia's Probiotic lozenges
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Head of Microbiology Department, Head of MiCORE Laboratory

Model Details: intervention group

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: April 19, 2021
• Study Start: March 22, 2021
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

ID (1)