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Completed

NCT Number: NCT06910397

The Effect of Probiotics on Gums Health and Bad Breath

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

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AL- Mustansiriyah University College of Dentistry

Baghdad, Iraq

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic Arm

Drug

one tablet daily for 28 days

Placebo

Other

placebo tablet once daily for 28 days

Primary outcomes

  1. oral health measures for 90 participant of both group

    Time frame: 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.

  2. Halitosis (90 participant of both group)

    Time frame: 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 outcomes

  1. The salivary biomarkers (90 participant of both group)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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