UMIN-CTR Clinical Trial

Basic information
Public title	The effect of toothbrush morphology on plaque and gingival inflammation relief for patients with multi-bracket device
Acronym	The effect of toothbrush morphology on plaque and gingival inflammation relief for patients with multi-bracket device
Scientific Title	The effect of toothbrush morphology on plaque and gingival inflammation relief for patients with multi-bracket device
Scientific Title:Acronym	The effect of toothbrush morphology on plaque and gingival inflammation relief for patients with multi-bracket device
Region	Japan

Condition
Condition	Malocclusion
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	According to this study, it becomes possible to provide more appropriate oral hygiene management guidance by clarifying the rate of removal of plaque by the form of toothbrush and the effect on periodontal tissue for patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measure the plaque index and the gingival index as the baseline data at the initial examination for the subject. Measurements of plaque index (PI) and gingival index (GI) are performed again one and three months after installation of the device.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Toothbrush that the subjects use during orthodontic treatment (DENT.EX Orthodontic-R) I
Interventions/Control_2	Toothbrush that the subjects use during orthodontic treatment ( pmj V7 compact head)
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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who visited the Okayama University Hospital Orthodontic clinic Patients with malocclusion More than 12 years old patients who are performed orthodontic treatment of all teeth Patients who got consent from themselves or relatives
Key exclusion criteria	Patients without malocclusion Patients with enamel hypoplasia Patients who have not yet erupted all teeth Patients with congenital syndrome Minor tooth movement Patients who will be not able to continue the treatment until finishing the treatment at Okayama University Hospital Orthodontic clinic Patients who are judged that they are inadequate by principal investigator or members of this study
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Kamioka
Organization	Graduate School of Medicine, Dentistry and pharmaceutical Science, Okayama University
Division name	Department of orthodontics
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama
TEL	086-235-6690
Email	kamioka@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Mana Middle name Last name Hashimoto
Organization	Graduate School of Medicine, Dentistry and pharmaceutical Science, Okayama University
Division name	Department of orthodontics
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama
TEL	086-235-6692
Homepage URL
Email	ph70319m@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	PMJ 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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama
Tel	086-235-6503
Email	mae6605@adm.okayama-u.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	2017 Year 11 Month 13 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	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 07 Day
Date of IRB	2018 Year 10 Month 19 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2022 Year 07 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 11 Month 09 Day
Last modified on	2020 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034084