The Effect of Probiotics on Gums Health and Bad Breath

Al-Mustansiriyah University88 enrolled

Overview

the study is about using healthy bacteria to improve the overall gingival and overall health and prevent or decrease the bad odor of the mouth caused by bad bacteria

The goal of this study is to verify the effect of Probiotics on oral Health Status and eliminate the gingival disease and Halitosis by measuring the levels of salivary biomarkers (cytokine IL-1b and proteases Matrix metalloproteinase (MMP-8) in saliva) and level of volatile sulfur compounds (VSCs) and their effects on improving gingival diseases clinical parameters in person age of (17-25) years old. The participants are randomly divided into two parallel groups (A, B). Group A will take probiotics and group B will take placebo for 28 days. The levels of IL-1b, MMP-8 in saliva, and VSCs measurement will be recorded respectively in different intervals of zero time and repeated on 14 days and 28 days. Statistical analysis will be done then comparative between two groups

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Gingivitis

Interventions

Probiotic ArmDRUG

one tablet daily for 28 days

PlaceboOTHER

placebo tablet once daily for 28 days

Eligibility

Sex: ALLMin age: 17 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

The Inclusion criteria * Subjects (male and female) between the age range 17-25 years old. * Subjects with mouth breathing habit. * Subjects with orthodontic and prosthodontic appliance * Race from Iraq. * Subjects having a dentition with ≥20 evaluable teeth (minimum of five teeth per quadrant). The Exclusion criteria * History of chronic disease. * History of systemic disease. * Patients with autoimmune diseases. * Patients under antibiotic treatment. * Pregnant, lactating females. * History of undergoing nonsurgical and surgical periodontal therapy in the last 6 months.

Locations (1)

AL- Mustansiriyah University College of Dentistry

Baghdad, Iraq

Outcomes

Primary Outcomes

oral health measures for 90 participant of both group

gingival index (scale 0-3),plaque index (scale 0-3), oral health index- simplex is composed of the Debris index and Calculus index (scoring six tooth segments in the mouth for each participants in both groups for the study and control group.

Time frame: four weeks(0day,14 day,28 day)

Halitosis (90 participant of both group)

Measuring the level of volatile sulfur compounds (VSCs) by use heliometer device (YRY Smart Breath Odor Detector), calculate social distance on (cm unite), detailed odor concentration on(ppm unite), and the related light color on the display screen for each participants in both groups the study and control group.

Time frame: four weeks(0 day,14 day, 28 day)

Secondary Outcomes

The salivary biomarkers (90 participant of both group)

Pro-inflammatory cytokine IL-1B (pg/ml). Matrix metalloproteinase neutrophil collagenase MMP-8 (pg/ml) for each participants in both groups the study and control group.

Time frame: four weeks (0 day,14 day ,28 day)

Data from ClinicalTrials.gov

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