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
1 other identifier
interventional
88
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2025
CompletedStudy Start
First participant enrolled
April 3, 2025
CompletedFirst Posted
Study publicly available on registry
April 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedAugust 11, 2025
February 1, 2025
1 month
March 20, 2025
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
The salivary biomarkers (90 participant of both group)
four weeks (0 day,14 day ,28 day)
Study Arms (2)
probiotic group
ACTIVE COMPARATOReach participant will take one tablet of probiotic daily for 28 days
placebo group-
PLACEBO COMPARATOReach participant will take one tablet of placebo tablet daily for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AL- Mustansiriyah University College of Dentistry
Baghdad, Iraq
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BAYDAA Y Alani, MSc student
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 20, 2025
First Posted
April 4, 2025
Study Start
April 3, 2025
Primary Completion
May 3, 2025
Study Completion
June 1, 2025
Last Updated
August 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share