UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018192 |
|---|---|
| Receipt number | R000021067 |
| Scientific Title | A prospective, multi-center, single-arm study of tOCP/Col for guided bone regeneration |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2018/07/09 18:50:19 |
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Basic information
Public title
A prospective, multi-center, single-arm study of tOCP/Col for guided bone regeneration
Acronym
A prospective, multi-center, single-arm study of OCP/Col
Scientific Title
A prospective, multi-center, single-arm study of tOCP/Col for guided bone regeneration
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tadashi Kawai |
Organization
Tohoku University Hospital
Division name
Oral and Maxillofacial Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8350
ta-shi@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Kawai |
Organization
Tohoku University Hospital
Division name
Oral and Maxillofacial Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Se
TEL
022-717-8350
Homepage URL
ta-shi@dent.tohoku.ac.jp
Sponsor or person
Institute
TOYOBO CO., LTD.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
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
| 2015 | Year | 07 | Month | 07 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021067
