UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047152 |
|---|---|
| Receipt number | R000053790 |
| Scientific Title | Development of Oral Care Support Application as Medical Device Program |
| Date of disclosure of the study information | 2022/03/11 |
| Last modified on | 2022/03/11 18:57:08 |
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Basic information
Public title
Development of Oral Care Support Application as Medical Device Program
Acronym
Development of Oral Care Support Application as Medical Device Program
Scientific Title
Development of Oral Care Support Application as Medical Device Program
Scientific Title:Acronym
Development of Oral Care Support Application as Medical Device Program
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop an application (medical device program) to support periodontal disease treatment that can be used by patients via smartphones, and to verify its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plaque control record
Preoperatively, 1 month, 3 months, and 6 months after the start of treatment (dummy in the control group), for a total of 3 times.
Key secondary outcomes
Probing Pocket Depth
Bleeding On Probing
Plaque Index
Gingival Index
Occult blood test
Preoperatively, 1 month, 3 months, and 6 months after the start of treatment (dummy in the control group), for a total of 3 times.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group (usual maintenance + periodontal disease treatment support application + measurement device) (Intervention period: 3 months after the start of the intervention)
Periodontal maintenance: Perform normal periodontal maintenance.
Fields to be entered by the patient in the application
-The presence and content of breakfast, lunch, dinner, and snacks
-Brushing after each meal, flossing, use of interdental brush
-Mouthwash use or not, sleep, exercise
-Read history of emails with advice sent by your DH
Items recorded by measuring instruments
-Precipitated blood reaction (using Perioscreen (Sunstar))
once per week
Interventions/Control_2
Control group (normal maint + dummy app + measuring device)
Periodontal maintenance: Perform normal periodontal maintenance.
Fields to be entered by the patient in the application
-Weight
-Meals
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
40 patients who visited Tokyo Medical and Dental University Hospital, completed periodontal disease treatment and were undergoing maintenance (no gender restriction)
Key exclusion criteria
Those with 19 or fewer remaining teeth
Those whose molars have less than 4 units of occlusal support
Removable Denture Users
Persons with temporomandibular joint disorder
Persons with verifiable oral motor impairment
Persons with mental illness
Currently receiving antimicrobial therapy
Persons with serious systemic illnesses (who have been judged by a physician to be unacceptable for participation in this study)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Digital Dentistry
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5379
m.kanazawa.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Mizutani |
Organization
Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-Ku, Tokyo
TEL
03-5803-5488
Homepage URL
mizuperi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Doctorbook
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
Tokyo Medical and Dental University Faculty of dentistry Institutional Review Board
Address
1-5-45, Yushima, Bunkyo-Ku, Tokyo,1138510
Tel
0358035404
d-hyoka.adm@tmd.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
東京医科歯科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 11 | 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
| 2022 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053790
