Periodontal DiseasesNCT06141083
Effect of TCI188 Probiotic on Oral Health
A study testing TCI188 Probiotic in people with Periodontal Diseases, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- TCI188 Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health
- Conditions
- Periodontal Diseases
- Being tested
- TCI188 Probiotic, Placebo
- Keywords
- Pediococcus acidilactici, Probiotics
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCI188 ProbioticDietary supplement
Also called Pediococcus acidilactici TCI188
take two tablets per day
PlaceboDietary supplement
take two tablets per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo chewable tablets | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| TCI188 Probiotic chewable tablets | Experimental | Not described Receives: Dietary Supplement: TCI188 Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of clinical oral measurements- Probing pocket depth (PPD)
The values of Probing pocket depth (PPD) was utilized to evaluate oral status.
Measured: 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.
Measured: 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)
The values of Plaque index (PI) was utilized to evaluate oral status.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The relative abundance of Streptococcus mutans, Porphyromonas gingivalis, Streptococcus salivarius, Pediococcus acidilactici were utilized to evaluate the change of oral microflora.
Measured: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
The change of liver function biomarkers (AST, ALT) of blood
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.
Measured: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
The change of renal function biomarkers (BUN, CRE) of blood
Fasting venous blood was sampled to measure renal function biomarkers- Blood urea nitrogen (BUN), Creatinine (CRE).
Measured: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
The change of inflammatory biomarkers (Hs-CRP, IL-10, IL-1beta) of blood
Fasting venous blood was sampled to measure inflammatory biomarkers- High-sensitivity CRP (Hs-CRP), Interleukin-10 (IL-10), Interleukin-1beta(IL-1beta).
Measured: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
The change of Bad breath
The Bad Breath Tester was utilized to measure Bad breath. The Bad breath detection level is 0~5.
Measured: before root planning, after root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Nov 2023
- Primary completion8 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chin-Wei Wang, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141083
- Sponsor's protocol ID
- N202307006
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TCI188 Probiotic on Oral Health
- ClinicalTrials.gov ID
- NCT06141083
- Acronym / sponsor ID
- N202307006
- Conditions
- Periodontal Diseases
- Keywords
- Pediococcus acidilactici, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of TCI188 (Pediococcus acidilactici) Probiotic on Oral Health
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo chewable tablets | Placebo comparator | Dietary Supplement: Placebo |
| TCI188 Probiotic chewable tablets | Experimental | Dietary Supplement: TCI188 Probiotic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCI188 ProbioticAlso: Pediococcus acidilactici TCI188take two tablets per day | Dietary supplement | TCI188 Probiotic chewable tablets |
| Placebotake two tablets per day | Dietary supplement | Placebo chewable tablets |
Primary outcome
The change of clinical oral measurements- Probing pocket depth (PPD)
Time frame: 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.
The change of clinical oral measurements- Bleeding on probing (BOP)
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
The values of Bleeding on probing (BOP) was utilized to evaluate oral status.
9 secondary outcomes
The change of clinical oral measurements- Plaque index (PI)
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)
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)
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
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 oral microflora
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
The change of liver function biomarkers (AST, ALT) of blood
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
The change of renal function biomarkers (BUN, CRE) of blood
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
The change of inflammatory biomarkers (Hs-CRP, IL-10, IL-1beta) of blood
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
The change of Bad breath
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Wei Wang principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCI188 Probiotic in people with Periodontal Diseases, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of clinical oral measurements- Probing pocket depth (PPD) (time frame: before root planning, after taking chewable tablets for 6-8 weeks, and after finishing taking chewable tablets for 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.