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Validity of measuring tooth brushing-induced gingival bleeding (t-BIGB) as a diagnostic method for gingivitis

A preliminary clinical study to examine the validity of measuring tooth brushing-induced gingival bleeding as a diagnostic method for gingivitis - t-BIGB study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051326
Enrollment
50
Registered
2023-08-18
Start date
2023-08-28
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

gingivitis, periodontal disease

Interventions

A dentist or dental hygienist thoroughly brushes all current teeth. After the brushing, the subject rinses his/her mouth lightly and leaves it for 1 minute. Then, the subject rinses his/her mouth with

Sponsors

Tokushima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Men and women who have 20 or more teeth.

Exclusion criteria

Exclusion criteria: 1. Subjects with dental diseases such as caries, periodontal disease, or oral mucosal diseases that require immediate treatment. 2. When consent to participate cannot be obtained from the research subject (and legally acceptable person). 3. In addition, when the research director or researcher determines that it is appropriate to stop the research.

Design outcomes

Primary

MeasureTime frame
To assess the correlation between levels of tooth brushing-induced gingival bleeding (BIGB) and that of gingival bleeding on probing (BOP).

Secondary

MeasureTime frame
Secondary endpoints include significant difference in BIGB level when gingivitis is diagnosed based on BOP 10% or 30%, cutoff value, respectively. The sensitivity and specificity by ROC analysis, correlation between BIGB positive tooth % and BOP positive site %, etc. will be also investigated.

Countries

Japan

Contacts

Public ContactHiro-O Ito

Tokushima University Graduate School of Biomedical Sciences Department of Preventive Dentistry

itohiro@tokushima-u.ac.jp088-633-7336

Outcome results

None listed

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