Clinical trial NCT06141083: Effect of TCI188 Probiotic on Oral Health
Official title: Effect of TCI188 Probiotic on Oral Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Keywords: Pediococcus acidilactici
Probiotics
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: The change of clinical oral measurements- Probing pocket depth (PPD)
timeFrame: before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of clinical oral measurements- Bleeding on probing (BOP)
timeFrame: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
Secondary outcomes:
measure: The change of clinical oral measurements- Plaque index (PI)
timeFrame: before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of clinical oral measurements- Clinical attachment level (CAL)
timeFrame: before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of clinical oral measurements- Gingival index (GI)
timeFrame: before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of inflammatory markers (IL-10, IL-1beta) of saliva
timeFrame: before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of oral microflora
timeFrame: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of liver function biomarkers (AST, ALT) of blood
timeFrame: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of renal function biomarkers (BUN, CRE) of blood
timeFrame: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of inflammatory biomarkers (Hs-CRP, IL-10, IL-1beta) of blood
timeFrame: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
measure: The change of Bad breath
timeFrame: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Chin-Wei Wang
role: PRINCIPAL_INVESTIGATOR
References: