Effect of TCI188 Probiotic on Oral Health

N/ACompletedNCT06141083

TCI Co., Ltd.55 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Periodontal Diseases

Interventions

TCI188 ProbioticDIETARY_SUPPLEMENT

take two tablets per day

PlaceboDIETARY_SUPPLEMENT

take two tablets per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Outcomes

Primary Outcomes

The change of clinical oral measurements- Probing pocket depth (PPD)

The values of Probing pocket depth (PPD) was utilized to evaluate oral status.

Time frame: 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.

Time frame: 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

The change of clinical oral measurements- Plaque index (PI)

The values of Plaque index (PI) was utilized to evaluate oral status.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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