Effect of TCI188 Probiotic on Oral Health

Not Applicable

Recruiting

• Conditions: Periodontal Diseases
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: TCI188 Probiotic

• Registration Number: NCT06141083
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo chewable tablets	Placebo	-
TCI188 Probiotic chewable tablets	TCI188 Probiotic	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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 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- 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 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.
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 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 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 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.

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan, Taiwan