Effect of TCI188 Probiotic on Oral Health

Study Overview
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Brief Summary
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To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health

Official Title
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Effect of TCI188 Probiotic on Oral Health

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Dietary Supplement: TCI188 Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 years old Participants suffer from severe periodontal disease throughout the mouth with symptoms at third and fourth stages, do not have immediate indications for the extraction of multiple teeth or complex denture stimulation, and have not undergone periodontal planing within one year. Exclusion Criteria: Participants have had periodontal or antimicrobial treatment within the past 6 months Participants are smokers, pregnant or with systemic diseases Participants had probiotic supplements or with history of adverse reactions to lactose or fermented dairy products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo chewable tablets<br> | Dietary Supplement: Placebo<br>* take two tablets per day<br>|
| Experimental: TCI188 Probiotic chewable tablets<br> | Dietary Supplement: TCI188 Probiotic<br>* take two tablets per day<br>* Other names: Pediococcus acidilactici TCI188;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediococcus acidilactici, Probiotics