The Effect of Probiotics on Gums Health and Bad Breath

Evaluating The Effect of Probiotics on Oral Health Status and Its Influence on The Gingival Disease and Halitosis in Iraq

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

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Probiotic Arm; Other: Placebo

Detailed Description

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
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Bagdad, Iraq
    • AL- Mustansiriyah University College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: probiotic group; each participant will take one tablet of probiotic daily for 28 days	Drug: Probiotic Arm; one tablet daily for 28 days
Placebo Comparator: placebo group-; each participant will take one tablet of placebo tablet daily for 28 days	Other: Placebo; placebo tablet once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	four weeks(0 day,14 day, 28 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	four weeks (0 day,14 day ,28 day)

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University
• Investigators: Principal Investigator: BAYDAA Y Alani, MSc student

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Actual): May 3, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: probiotics and gingival health
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis
• Other Study ID Numbers: MUPRV13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No