UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety test of dental implant that was immobilized growth factor derived from self-bone marrow stromal cell.
Title of the study (Brief title)	The safety test of CM immobilized implant.
Region	Japan

Condition
Condition	Missing teeth
Classification by specialty	Oral surgery Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The safety test of conditioned medium immobilized implant.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Symptom of allegy by cell derived conditioned medium. 1 week before implantation and immediately after implant surgery.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	The insertion of dental implant. The observation of dental implant.
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 growth og jaw is finished.
Key exclusion criteria	a.The bone volume is abundance to insert the dental implant. b. general condition is good c. alcohol, drug dependence patient d. oral hygiene is poor e. irradiated jaw f. lidocaine hydrochloride is incompatible drugs. g. metabolic bone disease h. The patient intake the bisphosphonete drug. i. pregnant
Target sample size	10

Research contact person
Name of lead principal investigator	HIBI Hideharu
Organization	The Nagoya University
Division name	Oral and Maxillofacial surgery
Address	65 Tsurumai, Showa-ku, Nagoya city
TEL	052-744-2348
Email	hibihi@med.nagoya-u.ac.jp

Public contact
Name of contact person	TSUCHIYA Shuhei
Organization	The Nagoya University Hospital
Division name	Oral and Maxillofacial Surgery
Address	65 Tsurumai, Showa-ku, Nagoya city
TEL	052-744-2348
Homepage URL	http://www.med.nagoya-u.ac.jp/medical/6391/6408/gakuganmengekagaku_soshakushougaiseigyogaku.html
Email	t-shuhei@med.nagoyoa-u.ac.jp

Sponsor
Institute	The Nagoya University Hospital
Institute
Department

Funding Source
Organization	N/A
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	2017 Year 12 Month 31 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 08 Month 31 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=R000010877