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To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo chewable tablets | Placebo Comparator |
| |
| TCI188 Probiotic chewable tablets | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCI188 Probiotic | Dietary Supplement | take two tablets per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of clinical oral measurements- Probing pocket depth (PPD) | The values of Probing pocket depth (PPD) was utilized to evaluate oral status. | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of clinical oral measurements- Bleeding on probing (BOP) | The values of Bleeding on probing (BOP) was utilized to evaluate oral status. | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of clinical oral measurements- Plaque index (PI) | The values of Plaque index (PI) was utilized to evaluate oral status. | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of clinical oral measurements- Clinical attachment level (CAL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin-Wei Wang | Taipei Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei, Taiwan | Taiwan |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Placebo | Dietary Supplement | take two tablets per day |
|
The values of Clinical attachment level (CAL) was utilized to evaluate oral status. |
| before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of clinical oral measurements- Gingival index (GI) | The values of Gingival index (GI) was utilized to evaluate oral status. | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of inflammatory markers (IL-10, IL-1beta) of saliva | The levels of interleukin-10 (IL-10), interleukin-1beta (IL-1beta) in saliva were utilized to evaluate oral inflammation status. | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of oral microflora | The relative abundance of Streptococcus mutans, Porphyromonas gingivalis, Streptococcus salivarius, Pediococcus acidilactici were utilized to evaluate the change of oral microflora. | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of liver function biomarkers (AST, ALT) of blood | Fasting venous blood was sampled to measure liver function biomarkers- Aspartate Transaminase (AST), Alanine aminotransferase (ALT), Blood urea nitrogen (BUN), Creatinine, High-sensitivity CRP (Hs-CRP), Interleukin. | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of renal function biomarkers (BUN, CRE) of blood | Fasting venous blood was sampled to measure renal function biomarkers- Blood urea nitrogen (BUN), Creatinine (CRE). | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of inflammatory biomarkers (Hs-CRP, IL-10, IL-1beta) of blood | Fasting venous blood was sampled to measure inflammatory biomarkers- High-sensitivity CRP (Hs-CRP), Interleukin-10 (IL-10), Interleukin-1beta(IL-1beta). | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |
| The change of Bad breath | The Bad Breath Tester was utilized to measure Bad breath. The Bad breath detection level is 0~5. | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks |