UMIN-CTR Clinical Trial

Basic information
Public title	An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Acronym	An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Scientific Title	An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Scientific Title:Acronym	An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Region	Japan

Condition
Condition	Periodontal disease
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effect of using an electric toothbrush during periodontal therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcomes are set at Plaque Control Record and the result of saliva test(ammonia). These outcomes will obtain at before and after periodontal therapy.
Key secondary outcomes	Secondary outcomes are set at periodontal condition (the percentage of probing depth deeper than 4mm, BOP, PISA) and results of saliva test (bacterial count, acidity, buffering capacity, WBC, protein).These outcomes will obtain at before and after periodontal therapy.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Participants assigned to use an electric tooth brush use an electric tooth blush (Hypersonic pro) during experimental period.
Interventions/Control_2	Participants assigned to use a hand tooth brush use a hand tooth blush (CURAPROX CS5460) during experimental period.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who come to the Department of Endodontics at Tohoku University Hospital, have at least one periodontal pocket of 4 mm or deeper in the periodontal examination.
Key exclusion criteria	People who are judged to have difficulty in using an electric toothbrush and to have difficulty in participating in the study due to psychosis or psychiatric symptoms.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Saito
Organization	Tohoku University Graduate School of Dentistry
Division name	Conservative Dentistry
Zip code	980-8575
Address	4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL	022-717-8343
Email	mssaito@dent.tohoku.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Saito
Organization	Tohoku University Graduate School of Dentistry
Division name	Conservative Dentistry
Zip code	980-8575
Address	4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL	022-717-8343
Homepage URL
Email	mssaito@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Fibermedicine
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	Tohoku University Graduate School of Dentistry, Research Ethics Committee
Address	4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
Tel	022-717-8343
Email	mssaito@dent.tohoku.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	2021 Year 05 Month 01 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	2021 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 13 Day
Last modified on	2021 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049622