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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic group | Active Comparator | each participant will take one tablet of probiotic daily for 28 days |
|
| placebo group- | Placebo Comparator | each participant will take one tablet of placebo tablet daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Arm | Drug | one tablet daily for 28 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The salivary biomarkers (90 participant of both group) | 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. | four weeks (0 day,14 day ,28 day) |
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The Inclusion criteria
The Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| BAYDAA Y Alani, MSc student | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AL- Mustansiriyah University College of Dentistry | Baghdad | Iraq |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2025 | Mar 14, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Other |
placebo tablet once daily for 28 days |
|
| D009057 |
| Stomatognathic Diseases |