UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016057 |
|---|---|
| Receipt number | R000018553 |
| Scientific Title | Effect of plaque removal on implant abutment using the ultrasonic water flow system |
| Date of disclosure of the study information | 2014/12/26 |
| Last modified on | 2015/08/05 21:59:53 |
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Basic information
Public title
Effect of plaque removal on implant abutment using the ultrasonic water flow system
Acronym
Effect of plaque removal on implant abutment using the ultrasonic water flow system
Scientific Title
Effect of plaque removal on implant abutment using the ultrasonic water flow system
Scientific Title:Acronym
Effect of plaque removal on implant abutment using the ultrasonic water flow system
Region
| Japan |
Condition
Condition
peri-implant disease, periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objects are to evaluate the efficacy of plaque removal effect on implant rough surface using the newly developed ultrasonic water flow system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of plaque change after treatment
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 plaque removal by ultrasonic water flow system
Interventions/Control_2
The plaque removal by brush cone
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 are the healing abutment can be attached.
Key exclusion criteria
Patients with acute symptoms (pain, swelling, redness)
active Infection (HIV, HBV, HCV)
Heart disease, blood disorder diabetes
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Takiguchi |
Organization
Showa University School of Dentistry
Division name
Periodontology
Zip code
Address
2-1-1 Kitasenzoku, Ohta-ku Tokyo
TEL
03-3787-1151
takigu@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Takiguchi |
Organization
Showa University School of Dentistry
Division name
Periodontology
Zip code
Address
2-1-1 Kitasenzoku, Ohta-ku Tokyo
TEL
03-3787-1151
Homepage URL
takigu@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Dentistry
Department of Periodontology
Institute
Department
Personal name
Funding Source
Organization
METI Development of Medical Device through Collaboration between Medicine and
Industry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2014 | Year | 12 | Month | 26 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 24 | 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
| 2014 | Year | 12 | Month | 25 | Day |
Last modified on
| 2015 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018553
| 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 |
