Evaluating The Effect of Probiotics on Oral Health Status and Its Influence on The Gingival Disease and Halitosis in Iraq
| Registry | NCT06910397 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 88 (Actual) |
| Sponsor | Al-Mustansiriyah University (Other) |
| Conditions | Gingivitis |
| Interventions | Probiotic Arm, Placebo (Drug, other) |
| Dates | start 2025-04-03, primary completion 2025-05-03, completion 2025-06-01, first posted 2025-04-04, last updated 2025-08-11 |
| Locations | 1 site in Iraq |
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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
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| probiotic group | Active comparator | Drug: Probiotic Arm | each participant will take one tablet of probiotic daily for 28 days |
| placebo group- | Placebo comparator | Other: Placebo | each participant will take one tablet of placebo tablet daily for 28 days |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| AL- Mustansiriyah University College of Dentistry | Baghdad | Iraq |