UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008954 |
|---|---|
| Receipt number | R000010501 |
| Scientific Title | Research on the actual condition survey on dental implant for periodontitis patients |
| Date of disclosure of the study information | 2012/09/21 |
| Last modified on | 2017/03/31 14:51:31 |
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Basic information
Public title
Research on the actual condition survey on dental implant for periodontitis patients
Acronym
The actual condition survey on dental implant
Scientific Title
Research on the actual condition survey on dental implant for periodontitis patients
Scientific Title:Acronym
The actual condition survey on dental implant
Region
| Japan |
Condition
Condition
Periodontitis, Peri-implant mucositis, Peri-implantitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is a prognosis over 3 years after the dental implant treatment for Japanese periodontitis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prognosis over 3 years after the dental implant treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who received regular supportive periodontal treatment over 3 years after the dental implant treatment.
Key exclusion criteria
The patient who could not receive regular supportive periodontal treatment.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yorimasa Ogata |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Department of Periodontology
Zip code
Address
2-870-1 Sakaecho-nishi, Matsudo, Chiba, Japan
TEL
047-36-9362
ogata.yorimasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yorimasa Ogata |
Organization
Japanese Society of Periodontology
Division name
Implant Committee
Zip code
Address
Kouku hoken kyoukai 1-43-9 Komagome, Toshima, Tokyo, JAPAN
TEL
03-3947-8891
Homepage URL
http://www.perio.jp
gakkai16@kokuhoken.or.jp
Sponsor or person
Institute
Japanese Society of Periodontology
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Periodontology
Organization
Division
Category of Funding Organization
Self funding
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
東京歯科大学（千葉県）、福岡歯科大学（福岡県）、松原歯科医院（岐阜県）、平野歯科医院（京都府）、日本大学松戸歯学部（千葉県）、有田歯科医院（東京都）、吉野歯科診療所歯周病インプラントセンター（神奈川県）、大阪大学歯学部（大阪府）、明海大学歯学部（埼玉県）、慶應義塾大学医学部（東京都）、新潟大学歯学部（新潟県）、愛知学院大学歯学部（愛知県）、岩手医科大学歯学部（岩手県）、日高歯科医院（東京都）、日本大学歯学部（東京都）、鹿児島大学歯学部（鹿児島県）、東北大学歯学部（宮城県）、石倉歯科医院（群馬県）、東京医科歯科大学歯学部（東京都）、浜松アクトタワー青山歯科室（静岡県）、昭和大学歯学部（東京都）、伊東会伊東歯科口腔病院（熊本県）、山王病院歯科口腔インプラントセンター（東京都）、北海道医療大学歯学部（北海道）、鶴見大学歯学部（神奈川県）、神奈川歯科大学（神奈川県）、佐瀬歯科医院（千葉県）、長谷川歯科医院（東京都）、児玉歯科医院（鹿児島県）、有楽歯科医院（神奈川県）、幸デンタルクリニック（茨城県）、松本歯科大学（長野県）、朝日大学歯学部（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
http://www.perio.jp
Publication of results
Published
Result
URL related to results and publications
http://doi.org/10.2334/josnusd.16-0027
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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
This reseach is intended for the patient who received regular supportive periodontal treatment over 3 years after the dental implant treatment.
Management information
Registered date
| 2012 | Year | 09 | Month | 21 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/03/31 | advpub_JOS2016 Implant実態調査.pdf |
