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Randomized double-blind study for the effect of theaflavin on oral bacterial flora

Randomized double-blind study for the effect of theaflavin on oral bacterial flora - Randomized double-blind study for the effect of theaflavin on oral bacterial flora

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020049
Enrollment
56
Registered
2015-12-03
Start date
2015-11-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Theaflavin tablet, 8 mg/2tablets/day, 6 weeks Placebo tablet, 0 mg/2 tablets/day, 6 weeks

Sponsors

University of Shizuoka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who are not appropriate to examine oral bacterial flora 2. Subjects who are not under treatment for dental caries and/or periodontal disease and have enough tooth (20 tooth<=)

Exclusion criteria

Exclusion criteria: 1. Subjects who are under treatment with mouse rinse 2. Subjects with diabetes, CKD, gastrointestinal diseases, lung diseases and/or cancer. 3. Subjects who are not appropriate to amount and pH of saliva. 4. Subjects with dental caries and/or periodontal disease 5. Subjects using removable denture 6. Antibiotics 7. drug and/or alcohol dependence 8. Pregnancy and nursing 9. Subjects who participate in other clinical trials at the time of this study entry

Design outcomes

Primary

MeasureTime frame
Periodontopathic-bacteria after taking teaflavin tablets for 3 or 6 weeks (1.P.gingivalis 2.F.nucleatum)

Secondary

MeasureTime frame
Following indicators after taking teaflavin tablets for 3 or 6 weeks 1) Gingival index:GI 2) Plaque index: PI 3) Bleeding on Probing: BOP 4) Cariogenic bacteria

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026