UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053724 |
|---|---|
| Receipt number | R000061307 |
| Scientific Title | Effect of an oral rinser with water flow containing cavitation bubbles in orthodontic patients |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2024/02/27 18:36:50 |
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Basic information
Public title
Effect of an oral rinser with water flow containing cavitation bubbles in orthodontic patients
Acronym
Effect of an oral rinser with water flow containing cavitation bubbles in orthodontic patients
Scientific Title
Effect of an oral rinser with water flow containing cavitation bubbles in orthodontic patients
Scientific Title:Acronym
Effect of an oral rinser with water flow containing cavitation bubbles in orthodontic patients
Region
| Japan |
Condition
Condition
malocclusion
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the effect of an oral rinser with water flow containing cavitation bubbles in orthodontic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Probing Depth(PD)
2)Plaque Control Record(PCR)
3)Bleeding on Probing(BOP)
4)Gingival Index(GI)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using oral rinser for 30 days
Interventions/Control_2
Not using oral rinser for 30 days
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Over 20 years old.
Those who are undergoing orthodontic treatment with multibrackets.
Those who have not taken PMTC for more than 3 months.
Key exclusion criteria
Persons with prosthetic devices spanning multiple teeth.
Persons with untreated teeth.
Persons with Multiple missing teeth.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Negishi |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Orthodontics
Zip code
271-8587
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9410
negishi.shinichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Ishii |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Orthodontics
Zip code
271-8587
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
TEL
047-360-9412
Homepage URL
ishii.kaori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
Panasonic Co.
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
Institutional Review Board in Nihon University School of Dentistry at Matsudo
Address
2-870-1, Sakaecho-Nishi, Matsudo, Chiba
Tel
047-368-6111
kj.md.ml@nihon-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
| 2024 | Year | 02 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061307
| 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 |
