Periodontal Diseases
Conditions
Keywords
Pediococcus acidilactici, Probiotics
Brief summary
To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health
Interventions
DIETARY_SUPPLEMENTTCI188 Probiotic
take two tablets per day
DIETARY_SUPPLEMENTPlacebo
take two tablets per day
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of clinical oral measurements- Probing pocket depth (PPD) | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | The values of Probing pocket depth (PPD) was utilized to evaluate oral status. |
| The change of clinical oral measurements- Bleeding on probing (BOP) | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | The values of Bleeding on probing (BOP) was utilized to evaluate oral status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of clinical oral measurements- Plaque index (PI) | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | The values of Plaque index (PI) was utilized to evaluate oral status. |
| The change of clinical oral measurements- Clinical attachment level (CAL) | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | The values of Clinical attachment level (CAL) was utilized to evaluate oral status. |
| The change of clinical oral measurements- Gingival index (GI) | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | The values of Gingival index (GI) was utilized to evaluate oral status. |
| The change of inflammatory markers (IL-10, IL-1beta) of saliva | before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | The levels of interleukin-10 (IL-10), interleukin-1beta (IL-1beta) in saliva were utilized to evaluate oral inflammation status. |
| 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 relative abundance of Streptococcus mutans, Porphyromonas gingivalis, Streptococcus salivarius, Pediococcus acidilactici were utilized to evaluate the change of oral microflora. |
| The change of liver function biomarkers (AST, ALT) of blood | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | 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. |
| The change of renal function biomarkers (BUN, CRE) of blood | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | Fasting venous blood was sampled to measure renal function biomarkers- Blood urea nitrogen (BUN), Creatinine (CRE). |
| The change of inflammatory biomarkers (Hs-CRP, IL-10, IL-1beta) of blood | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | Fasting venous blood was sampled to measure inflammatory biomarkers- High-sensitivity CRP (Hs-CRP), Interleukin-10 (IL-10), Interleukin-1beta(IL-1beta). |
| The change of Bad breath | before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks | The Bad Breath Tester was utilized to measure Bad breath. The Bad breath detection level is 0\~5. |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORChin-Wei Wang
Taipei Medical University Hospital
Outcome results
None listed