UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051326 |
|---|---|
| Receipt number | R000058495 |
| Scientific Title | A preliminary clinical study to examine the validity of measuring tooth brushing-induced gingival bleeding as a diagnostic method for gingivitis |
| Date of disclosure of the study information | 2023/08/18 |
| Last modified on | 2023/07/03 19:40:50 |
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Basic information
Public title
Validity of measuring tooth brushing-induced gingival bleeding (t-BIGB) as a diagnostic method for gingivitis
Acronym
BIGB study
Scientific Title
A preliminary clinical study to examine the validity of measuring tooth brushing-induced gingival bleeding as a diagnostic method for gingivitis
Scientific Title:Acronym
t-BIGB study
Region
| Japan |
Condition
Condition
gingivitis, periodontal disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Oral surgery |
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the validity of measuring tooth brushing-induced gingival bleeding as a diagnostic method for gingivitis.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the correlation between levels of tooth brushing-induced gingival bleeding (BIGB) and that of gingival bleeding on probing (BOP).
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
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 3 mL of distilled water for 10 seconds, and use the discharged liquid as the sample.
Interventions/Control_2
Following intervention 1 above, a usual gingivitis examination is performed. Periodontal probing using a probe with a blunt tip (periodontal probe) with a weak pressure of 20 g or less is performed on all current teeth by the 1-tooth 6-point method. Presence of induced bleeding (Bleeding on Probing: BOP) and probing depth for each measurement site will be recorded.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women who have 20 or more teeth.
Key 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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiro |
| Middle name | |
| Last name | Ito |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Preventive Dentistry
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7336
itohiro@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiro-O |
| Middle name | |
| Last name | Ito |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Preventive Dentistry
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7336
Homepage URL
itohiro@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramotocho, Tokushima
Tel
088-633-7958
brinshoshienk@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058495
