Effect of TCI188 Probiotic on Oral Health

NCT ID: NCT06141083

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo chewable tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

take two tablets per day

TCI188 Probiotic chewable tablets

Group Type EXPERIMENTAL

TCI188 Probiotic

Intervention Type DIETARY_SUPPLEMENT

take two tablets per day

Interventions

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TCI188 Probiotic

take two tablets per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

take two tablets per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Pediococcus acidilactici TCI188

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TCI Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chin-Wei Wang

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

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Taipei Medical University Hospital

Taipei, Taiwan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin-Wei Wang

Role: CONTACT

+886-2-27361661 ext. 5159

Ping Lin

Role: CONTACT

+886-02-87977811

Facility Contacts

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Chin-Wei Wang

Role: primary

+886-2-27361661 ext. 5159

Other Identifiers

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N202307006

Identifier Type: -

Identifier Source: org_study_id

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