UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective, multi-center, single-arm study of tOCP/Col for guided bone regeneration
Title of the study (Brief title)	A prospective, multi-center, single-arm study of OCP/Col
Region	Japan

Condition
Condition	bone defect
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of bone regeneration by OCP/Col application for bone defect
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sinus floor augmentation:Initial success degree of dental implant treatment, The insertion torque of a dental implant, Biopsy Socket preservation:The insertion torque of a dental implant, Biopsy Cystectomy:CT value Cleft palate operation:CT value
Key secondary outcomes	The implant stability quotient (ISQ) values, Radiographycal analysis.

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, socket preservation, cleft palate operation, or cystectomy.
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	7 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patient that socket presarvetion or sinus floor lift operation are adaptation before dental implant treatment. Patient with a cyst less than 3 cm. Patient with a cleft palate less than 2 cm in width.
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 has a bone metabolism disease like osteoporosis or has a medication of bisphosphonate. Patient who has a medication of steroid or immunosuppressant (The local administration is excluded). Patient who receives an anticoagulant therapy. Patient who is pregnant, possibly pregnant, nursing or considering pregnancy. Patient who has an uncontroled diabetes. Smoker, but the patient who was able to confirm intention of the smoking cessation before clinical trial participation is excluded. 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	60

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, Se
TEL	022-717-8350
Homepage URL
Email	ta-shi@dent.tohoku.ac.jp

Sponsor
Institute	TOYOBO CO., LTD.
Institute
Department

Funding Source
Organization	TOYOBO CO., LTD.
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	東北大学病院（宮城県）、慶應義塾大学医学部（東京都）、長崎大学歯学部（長崎県）、山形大学医学部（山形県）、秋田大学医学部（秋田県）、鹿児島大学病院（鹿児島県）、横浜総合病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 07 Day
Anticipated trial start date	2015 Year 07 Month 07 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 09 Month 30 Day

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

Management information
Registered date	2015 Year 07 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=R000021067