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The Effect of Probiotics on Gums Health and Bad Breath

NCT06910397 — Not applicable, Completed, 88 participants, Al-Mustansiriyah University

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

RegistryNCT06910397
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment88 (Actual)
SponsorAl-Mustansiriyah University (Other)
ConditionsGingivitis
InterventionsProbiotic Arm, Placebo (Drug, other)
Datesstart 2025-04-03, primary completion 2025-05-03, completion 2025-06-01, first posted 2025-04-04, last updated 2025-08-11
Locations1 site in Iraq

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-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

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+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

+Arms and interventions

ArmTypeInterventionsDescription
probiotic groupActive comparatorDrug: Probiotic Armeach participant will take one tablet of probiotic daily for 28 days
placebo group-Placebo comparatorOther: Placeboeach participant will take one tablet of placebo tablet daily for 28 days
  • Probiotic Arm (Drug): one tablet daily for 28 days
  • Placebo (Other): placebo tablet once daily for 28 days

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 17 Years to 25 Years, accepts healthy volunteers

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)

FacilityCityCountryStatus
AL- Mustansiriyah University College of DentistryBaghdadIraq

+Study documents

+Investigators

  • BAYDAA Y Alani, MSc student, Principal investigator

My Notes