NCT06141083

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

November 15, 2023

Last Update Submit

February 2, 2026

Conditions

Periodontal Diseases

Keywords

Pediococcus acidilacticiProbiotics

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • 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 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 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 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 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

  • +4 more secondary outcomes

Study Arms (2)

Placebo chewable tablets

PLACEBO COMPARATOR
Dietary Supplement: Placebo

TCI188 Probiotic chewable tablets

EXPERIMENTAL
Dietary Supplement: TCI188 Probiotic

Interventions

TCI188 ProbioticDIETARY_SUPPLEMENT

take two tablets per day

Also known as: Pediococcus acidilactici TCI188
TCI188 Probiotic chewable tablets
PlaceboDIETARY_SUPPLEMENT

take two tablets per day

Placebo chewable tablets

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Chin-Wei Wang

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

November 1, 2023

Primary Completion

December 8, 2025

Study Completion

January 30, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

TW(1)