UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016207 |
|---|---|
| Receipt number | R000018806 |
| Scientific Title | Clinical study for development of the ultrasonic water flow system |
| Date of disclosure of the study information | 2015/01/14 |
| Last modified on | 2015/08/13 09:40:58 |
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Basic information
Public title
Clinical study for development of the ultrasonic water flow system
Acronym
Clinical study for development of the ultrasonic water flow system
Scientific Title
Clinical study for development of the ultrasonic water flow system
Scientific Title:Acronym
Clinical study for development of the ultrasonic water flow system
Region
| Japan |
Condition
Condition
peri-implantitis, implantitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the efficacy of plaque removal on rough surface of dental implant using the ultrasonic water flow system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the amount of plaque after treatment using the ultrasonic water flow system
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
the removal of dental plaque by the ultrasonic water flow system
Interventions/Control_2
the removal of dental plaque by rubber tip
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
subjects who have dental implants are able to be attached the healing abutment
Key exclusion criteria
Patient with acute symptoms(pain, swelling, redness)
Patient with HBV, HCV or HIV infection
Patient with diabetes, heart disease and blood disorder
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michihiko Usui |
Organization
Kyushu Dental University
Division name
Division of Periodontology
Zip code
Address
2-6-1, Manazuru, Kokurakitaku, Kitakyushu, Fukuoka
TEL
093-582-1131
r12usui@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michihiko Usui |
Organization
Kyushu Dental University
Division name
Division of Periodontology
Zip code
Address
2-6-1, Manazuru, Kokurakitaku, Kitakyushu, Fukuoka
TEL
093-582-1131
Homepage URL
r12usui@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Department of Periodontology, Showa University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
METI Development of Medical Divice through Collaboration between Medicine and Industry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 14 | 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
| 2014 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 13 | Day |
Last modified on
| 2015 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018806
