UMIN-CTR Clinical Trial

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

Sponsor
Institute	Kyushu University Faculty of Dental Science Implant and Rehabilitative Dentistry
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015940