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
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
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
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
