UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety analysis of dental implant immobilized conditioned medium derived from autologous conditioned medium.
Title of the study (Brief title)	The safety analysis of dental implant immobilized conditioned medium.
Region	Japan

Condition
Condition	missing teeth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To ensure the safety of dental implant that is immobilized conditioned medium.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Xray, WBC, RBC, PLT, GTP, GOP, LDH, IgA, clinical observation 1,2 weeks, 1,3,6,12month after implantation
Key secondary outcomes

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The insert the dental implant that is ibimmobilized conditioned medium. One time.
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	The patient that want to treat the denal implant for missing teeth. The patient that has the bone quantity to insert the 13mm length implant.
Key exclusion criteria	The patient that don't have the enough bone to insert the implant. The patient with the dependency of a patient, the drug which an operation by the local anesthesia has an impossible serious whole body disease and the alcohol, an oral hygiene state are bad, and improvement excludes the patient that it is not admitted from this study after the instruction. In addition, there is the past of the malignant tumor, and the radiotherapy that top and bottom jawbone is in the irradiation range, the patient with the past of the chemotherapy exclude it. In addition, the patient having HIV, HCV, HBV, an infectious disease of the HTLV excludes it.
Target sample size	10

Research contact person
Name of lead principal investigator	Hibi Hideharu
Organization	Nagoya University Hospital
Division name	Oral and Maxillifacial Surgery
Address	Tsurumai-cho 65 Showa-ku Nagoya-city Aichi
TEL	052-744-2348
Email	hibihi@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tsuchiya Shuhei
Organization	Nagoya University Hospital
Division name	Oral and Maxillifacial Surgery
Address	65 Showa-ku Nagoya-city Aichi
TEL	052-744-2348
Homepage URL
Email	t-shuhei@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Nagoya University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 09 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 06 Day
Anticipated trial start date	2012 Year 12 Month 06 Day
Last follow-up date	2015 Year 12 Month 05 Day
Date of closure to data entry	2015 Year 12 Month 05 Day
Date trial data considered complete	2015 Year 12 Month 05 Day
Date analysis concluded	2015 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 09 Day
Last modified on	2016 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021930