UMIN-CTR Clinical Trial

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
Email	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
Email	mizuperi@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053790