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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017257
Receipt No. 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

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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
Email 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
Email haraguchi0711@dent.kyushu-u.ac.jp

Sponsor
Institute Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation, Faculty of Dental Science, Kyushu University
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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