UMIN-CTR Clinical Trial

Basic information
Public title	A study on effect of professional instruction for efficiency to remove dental plaque on patients first using an electric toothbrush
Acronym	Effect of professional instruction for patients first using an electric toothbrush
Scientific Title	A study on effect of professional instruction for efficiency to remove dental plaque on patients first using an electric toothbrush
Scientific Title:Acronym	Effect of professional instruction for patients first using an electric toothbrush
Region	Japan

Condition
Condition	Periodontitis, gingivitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the efficacy of professional instructions for removing dental plaque on the patient using an electric toothbrush for the first time.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plaque Index after two weeks using an electrical toothbrush
Key secondary outcomes	Gingival Index after two weeks using an electrical toothbrush

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Receive professional instruction before using an electric toothbrush
Interventions/Control_2	Use an electric toothbrush without professional instruction
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Volunteer who has never used an electric toothbrush and has target teeth, and no prosthetic for them. Subjects with probing depth <= 4 mm
Key exclusion criteria	Dentistry worker Subjects who are treated for periodontal disease within three months
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takahiko Middle name Last name Morotomi
Organization	Kyushu Dental University
Division name	Division of Endodontics and Restorative Dentistry
Zip code	803-8580
Address	2-6-1 Manazuru, Kokurakita-ku, Kitakyushu 803-8580 Japan
TEL	+81-93-582-1131
Email	r13morotomi@fa.kyu-dent.ac.jp

Public contact
Name of contact person	1st name Takahiko Middle name Last name Morotomi
Organization	Kyushu Dental University
Division name	Division of Endodontics and Restorative Dentistry
Zip code	803-8580
Address	2-6-1 Manazuru, Kokurakita-ku, Kitakyushu 803-8580 Japan
TEL	+81-93-582-1131
Homepage URL
Email	r13morotomi@fa.kyu-dent.ac.jp

Sponsor
Institute	Kyushu Dental University
Institute
Department

Funding Source
Organization	Kyushu Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokuyama dental Corp.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu Dental Univercity
Address	2-6-1 Manazuru, Kokurakita-ku, Kitakyushu City.
Tel	093-582-1131
Email	r13morotomi@fa.kyu-dent.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	九州歯科大学附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 04 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	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 31 Day
Date of IRB	2017 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 08 Month 07 Day
Last follow-up date	2022 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	2017 Year 08 Month 04 Day
Last modified on	2021 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032655