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Completed

NCT Number: NCT06141083

Effect of TCI188 Probiotic on Oral Health

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

Completed

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCI188 Probiotic

Dietary Supplement

take two tablets per day

Other names: Pediococcus acidilactici TCI188

Placebo

Dietary Supplement

take two tablets per day

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

  2. 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 values of Clinical attachment level (CAL) was utilized to evaluate oral status.

  3. 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 values of Gingival index (GI) was utilized to evaluate oral status.

  4. 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 levels of interleukin-10 (IL-10), interleukin-1beta (IL-1beta) in saliva were utilized to evaluate oral inflammation status.

  5. 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 relative abundance of Streptococcus mutans, Porphyromonas gingivalis, Streptococcus salivarius, Pediococcus acidilactici were utilized to evaluate the change of oral microflora.

  6. 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

    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.

  7. 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

    Fasting venous blood was sampled to measure renal function biomarkers- Blood urea nitrogen (BUN), Creatinine (CRE).

  8. 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

    Fasting venous blood was sampled to measure inflammatory biomarkers- High-sensitivity CRP (Hs-CRP), Interleukin-10 (IL-10), Interleukin-1beta(IL-1beta).

  9. 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

    The Bad Breath Tester was utilized to measure Bad breath. The Bad breath detection level is 0~5.

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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