UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bone augmentation by octacalcium and collagen composite
Title of the study (Brief title)	Bone augmentation by OCP/Collagen
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of bone augmentation and safety by OCP/Collagen
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Histological analysis, Radiographycal analysis, Safety assessment by clinical examination and adverse event
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Implantation of OCP/Collagen as a bone sbstitute material with sinus floor augmentation.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Inpatient/Outpatient: no specification Disease/ Severity: Missing tooth with below 10 mm from sinus floor to alveolar crest of radiographic examination Affected period: no specification Treatment period: no specification Patients who can provide written informed consent
Key exclusion criteria	Patient suffering severe hepatopathy, renal disorders, and heart disease who would affect safety evaluation of this trial Patient who has an allergy drug Patient who is pregnant, possibly pregnant, nursing or considering pregnancy Patient who participated other clinical trial program within 3 months prior to the study entry Others, patient who is unfit for the study as determined by the principal investigator or sub-investigators
Target sample size	11

Research contact person
Name of lead principal investigator	Tadashi Kawai
Organization	Tohoku University Hospital
Division name	Oral and Maxillofacial Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
TEL	022-717-8350
Email	ta-shi@dent.tohoku.ac.jp

Public contact
Name of contact person	Tadashi Kawai
Organization	Tohoku University Hospital
Division name	Oral and Maxillofacial Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi
TEL	022-717-8350
Homepage URL
Email	ta-shi@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
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	2014 Year 12 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 10 Day
Anticipated trial start date	2014 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 12 Month 04 Day
Last modified on	2018 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018447