UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029897
Receipt number R000034084
Scientific Title The effect of toothbrush morphology on plaque and gingival inflammation relief for patients with multi-bracket device
Date of disclosure of the study information 2017/11/13
Last modified on 2020/05/12 23:48:30

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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 or person

Institute

Okayama University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name