The Effect of Probiotics on Gums Health and Bad Breath

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Drug: Probiotic Arm; Other: Placebo

• Registration Number: NCT06910397
• Lead Sponsor: Al-Mustansiriyah University

Brief Summary

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

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-27
• Study Start: 2025-04-03
• Study First Posted: 2025-04-04
• Primary Completion: 2025-05-03
• Study Completion: 2025-06-01
• Last Update Submitted: 2025-08-08
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic group	Probiotic Arm	each participant will take one tablet of probiotic daily for 28 days
placebo group-	Placebo	each participant will take one tablet of placebo tablet daily for 28 days

Primary Outcome Measures

Name	Time	Method
oral health measures for 90 participant of both group	four weeks(0day,14 day,28 day)	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.
Halitosis (90 participant of both group)	four weeks(0 day,14 day, 28 day)	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.

Secondary Outcome Measures

Name	Time	Method
The salivary biomarkers (90 participant of both group)	four weeks (0 day,14 day ,28 day)	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.

Trial Locations

Locations (1)

AL- Mustansiriyah University College of Dentistry; 🇮🇶 Bagdad, Iraq