Effect of a probiotic on oral health in patients with periodontal disease
Effect of TCI188 Probiotic on Oral Health
This study is testing if a probiotic can help improve oral health for people with severe gum disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | TCI Co., Ltd. Industry-sponsored |
| Locations | 1 site (Taipei, Taiwan) |
| Trial ID | NCT06141083 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of TCI188, a probiotic containing Pediococcus acidilactici, in improving oral health among individuals suffering from severe periodontal disease. Participants will be randomly assigned to receive either the probiotic or a placebo, and their oral health outcomes will be monitored over the course of the study. The focus is on patients with advanced stages of periodontal disease who have not received recent periodontal treatment. The goal is to determine if the probiotic can provide significant benefits in managing this condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with severe periodontal disease who have not undergone recent periodontal treatment.
Not a fit: Patients who have received periodontal or antimicrobial treatment in the past six months, are smokers, pregnant, or have systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this probiotic treatment could offer a novel, non-invasive option for improving oral health in patients with severe periodontal disease.
How similar studies have performed: While the use of probiotics in oral health is an emerging field, this specific approach with TCI188 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei, Taiwan
- Taipei Medical University Hospital — Taipei, Taiwan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chin-Wei Wang — Taipei Medical University Hospital
- Study coordinator: Chin-Wei Wang
- Email: jeffwa@tmu.edu.tw
- Phone: +886-2-27361661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.