UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062788 |
|---|---|
| Receipt number | R000071886 |
| Scientific Title | An evaluation study on the effect of oral care instruction, including the use of rubber interdental brushes, on maintaining oral hygiene status at furcation involvement sites |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/02 17:39:05 |
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Basic information
Public title
An evaluation study on the effect of oral care instruction, including the use of rubber interdental brushes, on maintaining oral hygiene status at furcation involvement sites
Acronym
Effect of comprehensive oral care instruction including rubber interdental brushes on gaps between tooth roots
Scientific Title
An evaluation study on the effect of oral care instruction, including the use of rubber interdental brushes, on maintaining oral hygiene status at furcation involvement sites
Scientific Title:Acronym
Effect of comprehensive oral care instruction including rubber interdental brushes on oral hygiene maintenance at furcation involvement sites
Region
| Japan |
Condition
Condition
furcation involvement
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of oral care instruction, including guidance on the use of rubber interdental brushes, on the oral hygiene status of patients with furcation involvement..
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire
Key secondary outcomes
Bleeding on Probing, Probing Pocket Depth, Gingival Index, Plaque bacterial count, Clinical observations, Subject diary
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients will be instructed to brush their teeth at least twice daily using the designated oral care products (toothbrush and toothpaste), and to use a rubber interdental brush on the target site(s) at least once daily
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Male and female patients aged 20 to 79 years (inclusive) at the time of obtaining informed consent.
2) Patients who have at least one Class III furcation involvement (a lesion where a periodontal probe passes completely through the furcation) with a tooth mobility of degree 2 or less.
3) Patients with bleeding on probing (BOP) at the target furcation involvement site.
4) Patients who have not performed self-care using an interdental brush and dental floss at the target furcation involvement site for 3 months prior to and up to the time of obtaining informed consent.
5) Patients who have received a sufficient explanation of the purpose and details of the study, have fully understood them, have voluntarily decided to participate, and have provided written informed consent.
Key exclusion criteria
1) Patients currently receiving treatment for oral diseases, including periodontal disease (e.g., scaling, root planing, or surgical treatment). In addition, patients currently receiving care at any dental clinic other than the study site (Takai Dental Clinic).
2) Patients with a past or current history of psychiatric disorders.
3) Patients who have used oral antibiotics within 3 months prior to the start of the study. In addition, patients who have used bactericidal/antibacterial mouthwashes or oral anti-inflammatory drugs (e.g., NSAIDs) within 1 month prior to the start of the study.
4) Patients who are currently pregnant or breastfeeding, or who plan to become pregnant during the study period.
5) Patients with a history of allergic reactions to toothpaste or rubber.
6) Patients with excessive alcohol consumption habits (reference: 40 g or more of pure alcohol per day).
7) Patients who have a habit of smoking 1 pack (20 cigarettes) or more per day (heavy smokers).
8) Patients who plan to make significant changes to their lifestyle habits (e.g., diet, sleep, or exercise habits) during the study period, such as taking a long trip.
9) Patients with an extremely irregular diet, or those with irregular daily rhythms, such as shift workers or night-shift workers.
10) Patients currently participating in another clinical trial, those within 4 weeks of completing another clinical trial, or those planning to participate in another clinical trial after consenting to this study.
11) Other patients deemed inappropriate for the study by the Principal Investigator (e.g., patients who have difficulty using an interdental brush due to hand tremors, or patients for whom the insertion of an interdental brush is anatomically impossible).
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Kuramitsu |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Healthcare Product Development Dept. R&D Headquarters
Zip code
562-0029
Address
4-1-66, Saito aokita. Minoh, Osaka, Japan
TEL
(06)-6231-1144
s.kuramitsu@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Takai |
Organization
TAKAI Dental Clinic
Division name
Vice Director
Zip code
370-0851
Address
1770 Kaminakaimachi, Takasaki, Gunma, Japan
TEL
027-384-6480
Homepage URL
info@takai-dc.com
Sponsor or person
Institute
Kobayashi Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2026 | Year | 09 | Month | 02 | 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
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071886
