Effect of TCI188 Probiotic on Oral Health

Periodontal Diseases Clinical Trial

Official title:

Effect of TCI188 Probiotic on Oral Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141083
• Other study ID #: N202307006
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: TCI Co., Ltd.
• Contact: Chin-Wei Wang
• Phone: +886-2-27361661
• Email: jeffwa[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Dietary Supplement:
• TCI188 Probiotic
take two tablets per day
• Placebo
take two tablets per day

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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