UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013718 |
|---|---|
| Receipt number | R000015940 |
| Scientific Title | Clinical evaluation research of GC Implant Aadva |
| Date of disclosure of the study information | 2014/04/15 |
| Last modified on | 2022/05/09 17:22:48 |
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Basic information
Public title
Clinical evaluation research of GC Implant Aadva
Acronym
Clinical evaluation research of GC Implant Aadva
Scientific Title
Clinical evaluation research of GC Implant Aadva
Scientific Title:Acronym
Clinical evaluation research of GC Implant Aadva
Region
| Japan |
Condition
Condition
single or continuous two teeth loss
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study to evaluate the 3 years clinical result of GC Implant Aadva in single or continuous two teeth loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amount of marginal bone loss after implant loading
Key secondary outcomes
Evaluation of implant success/survival
Shaking of implant and pain
Rubor of peri implant tissue
Pus discharge
Exposure of implant
Oral hygiene
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A study to evaluate the 3 years clinical result of GC Implant Aadva in single or continuous two teeth loss
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subjects whom state of loss corresponds to either of condition in the following
Subjects with single or continuous two teeth loss
Subjects with 3 unit teeth loss from second primolar to second molar and no dental antagonist at second molar positon
2.Subjects with excellent general status.
3.Subjects with natural or restored medial and distal adjacent teeth to the missing tooth. The condition of the adjacent teeth will not change during this study.
4.Subjects with following bite condition
Subjects with A and B1 in Eichner classification
Subjects with B2 in Eichner classification and with support zone on the both side
5.Subjects who has dental antagonist irrespective of natural tooth, implant and denture.
6.Subjects with O Leary s Plaque Control score of <20% at screening.
7.Subjects with sufficient bone mass(Bone width 6mm or more of the platform position, Bone height 10mm or more(in lower jow the distance between the mandibular canal)) in the implant placement site.
8.Subjects who sign consent forms to show their agreement to take part in the study
9.Subjects (male and female) aged 20 years or older.
Key exclusion criteria
1.Subjects with a systemic disease that may affect the implant treatment, diabetes for example
2.Subjects with any of the diseases that is contraindicated or relatively contraindicated in oral surgical treatment disorders
3.Subjects with tooth root at planned implantation
4. Subjects with bone graft to the extraction socket
5. Subjects with an untreated tooth that needs endodontic care in an adjacent part of the implant placement site
6. Subjects with a 4-mm or deeper periodontal pocket in an adjacent tooth of the implant placement site
7. Subjects with un-control of periodontal disease
8. Subjects with severe habits of bruxism or clenching
9. Subjects with extremely short intermaxillary distance or notable trismus due to temporomandibular joint dysfunction
10. Subjects with extreme occlusion failure
11. Subjects who smoke more than 10 cigarettes a day or subjects who cannot stop smoking for 2 weeks before and after the implant placement surgery
12. Subjects who plan to participate in other clinical trial, or investigation 30 days prior to or during this study
13. Subjects who are pregnant or nursing or subjects who plan to be pregnant during this study
14. Subjects who cannot understand this study or subjects that the investigator deems ineligible to participate in this study
15. Subjects who can not be mutual understanding or mental illness
16. Uncooperative subjects to treatment
17. Subjects who need sinus lift
18. Subjects with a history of failure of implant placement in the site where an implant is planned to be placed in this study
19. Subjects within 12 weeks of tooth extraction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Koyano |
Organization
Kyushu University Faculty of Dental Science
Division name
Implant and Rehabilitative Dentistry
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
TEL
092-642-6376
koyano@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichiro Ogino |
Organization
Kyushu University Faculty of Dental Science
Division name
Implant and Rehabilitative Dentistry
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
TEL
092-642-6441
Homepage URL
ogino@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Faculty of Dental Science
Implant and Rehabilitative Dentistry
Institute
Department
Personal name
Funding Source
Organization
GC Corporation
Organization
Division
Category of Funding Organization
Profit 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 | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 11 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 15 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015940
