UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043193 |
|---|---|
| Receipt number | R000049274 |
| Scientific Title | Changes in brushing motivation due to the notification of oral malodor in orthodontic patient |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/02/02 13:37:36 |
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Basic information
Public title
brushing motivation and oral malodor in orthodontic patient
Acronym
brushing motivation and oral malodor in orthodontic patient
Scientific Title
Changes in brushing motivation due to the notification of oral malodor in orthodontic patient
Scientific Title:Acronym
Changes in brushing motivation due to the notification of oral malodor in orthodontic patient
Region
| Japan |
Condition
Condition
malocclusion / malodor
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change in brushing motivation caused by the notification of oral malodor in orthodontic treatment patients, using VSC levels and Periodontol tissue examination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VSC level,PCR,BOP,PD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
notification of VSC level
Interventions/Control_2
non-notification of VSC level
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
patients who came to the orthodontic department and were applied with multi bracket appliance on both upper and lower jaw
Key exclusion criteria
patients with jaw abnormality, systemic disease, drug administration in the past 4 months, poker depths of 4mm or more, and birth defects as CLP
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | takashi |
| Middle name | |
| Last name | ono |
Organization
Tokyo Medical Dental University
Division name
orthodontic
Zip code
113-8510
Address
Yushima1-5-45,bunnkyouku,tokyo
TEL
03-5803-4146
t.ono.orts@tmd.ac.jp
Public contact
Name of contact person
| 1st name | YUMI |
| Middle name | |
| Last name | NAKANO |
Organization
Tokyo Medical Dental University
Division name
orthodontic
Zip code
113-8510
Address
yumi.n1229@gmail.comshima1 5-45,bunkyouku,tokyo
TEL
03-5803-4146
Homepage URL
nakanoyumi.orts@gmail.com
Sponsor or person
Institute
Tokyo Medical Dental University
Institute
Department
Personal name
Funding Source
Organization
orthodontic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University ethics commity
Address
yushima1-5-45, bunnkoyuku,Tokyo
Tel
03-5803-4712
jimubu-sanren.adm@tdm.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 | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | 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 | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049274
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
