UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017257 |
|---|---|
| Receipt number | R000019798 |
| Scientific Title | The effect of hydrothermal treatment of the titanium implant on the peri-implant microflora |
| Date of disclosure of the study information | 2015/04/23 |
| Last modified on | 2017/02/26 14:17:25 |
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Basic information
Public title
The effect of hydrothermal treatment of the titanium implant on the peri-implant microflora
Acronym
The effect of hydrothermal treatment of the titanium implant on the peri-implant microflora
Scientific Title
The effect of hydrothermal treatment of the titanium implant on the peri-implant microflora
Scientific Title:Acronym
The effect of hydrothermal treatment of the titanium implant on the peri-implant microflora
Region
| Japan |
Condition
Condition
Partial edentulism treated with dental implants
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of hydrothermal treatment of the titanium implant on the peri-implant microflora
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral flora analysis
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
gamma-ray sterilization (control group)
Interventions/Control_2
hydrothermal treatment (experimental group)
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
1)The patients treated with more than two Nobel Biocare RP Branemark implants in their molar region with two-stage implantation surgery
2)The patients with at least 1mm in thickness of their gingiva from the implant shoulder
Key exclusion criteria
1)The patients who do not agree to participate in this study on document-based informed consent format
2)The presence of occlusal contact to the opposing teeth when healing abutments and washers are connected
3)The exposure of washers to the oral cavity when healing abutments and washers are connected
4)Implant Stability Quotient (ISQ) is 45 or less at the time of second-stage operation
5)The mobility of the implant body
6)The usage of removable partial denture in the healing period at the implant site
7)The patients with titanium allergy, and/or misfit of the implant treatment
8)The difficulty of following this protocol
9)The loosing of healing abutment during the observation period
10)The patients with beta-lactam antibiotics allergy
11)The patients under 20 years old
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Koyano |
Organization
Faculty of Dental Science, Kyushu University
Division name
Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6441
koyano@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Haraguchi |
Organization
Faculty of Dental Science, Kyushu University
Division name
Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6441
Homepage URL
haraguchi0711@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
| 2015 | Year | 04 | Month | 23 | 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
This study was finished, because adaptation case was decreased.
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2016 | 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
| 2015 | Year | 04 | Month | 23 | Day |
Last modified on
| 2017 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019798
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
