UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012953 |
|---|---|
| Receipt number | R000015145 |
| Scientific Title | Research on wound healing in oral surgery by plasma rich in growth factor (PRGF) |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2016/03/15 16:26:34 |
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Basic information
Public title
Research on wound healing in oral surgery by plasma rich in growth factor (PRGF)
Acronym
Research on wound healing in oral surgery by PRGF
Scientific Title
Research on wound healing in oral surgery by plasma rich in growth factor (PRGF)
Scientific Title:Acronym
Research on wound healing in oral surgery by PRGF
Region
| Japan |
Condition
Condition
Extraction of impacted wisdom tooth, upper jaw sinus lift, jaw bone cyst, tumor of jaw, facial laceration, fracture of the jaw, other PRGF adaptation cases
Classification by specialty
| Surgery in general | Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
PRGF therapy that the promoting effect of healing regenerative capacity of the hard and soft both organizations can be expected, there is a value of dental clinical research. The purpose of this study is to examine the oral mucosa of postoperative wound healing promoting effect of PRGF for the jaw bone loss, such as the skin and loss of face caused by oral surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the new bone formation ability of PRGF, periodontal pocket healing is inspection at the time of one month, three months, six months after surgery by Using X-ray inspection. Also the day after surgery and, for one week, measurement of wound closure time basis over time oral photograph at (inspection), presence or absence of open wounds City, epithelial promoting ability, 1 month, 3 months I do whether presence or absence of infection trend.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PRGF-treated group
Interventions/Control_2
non PRGF-treated group
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
| 10 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Extraction of an impacted wisdom tooth Winter classification Class 3 or more, upper jaw sinus lift surgery, jaw bone cyst, tumor of jaw , fracture of the jaw, other PRGF adaptation case patients
Key exclusion criteria
Infections and patients with systemic disease, pregnant women
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahashi Kosuke |
Organization
Nihon university school of dentistry at matsudo
Division name
Maxillofacial surgery
Zip code
Address
2-870-1 sakaecyo-nishi matudo city chiba
TEL
047-360-9395
takahashi.kosuke@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | takahashi kosuke |
Organization
nihon university school of dentistry at matsudo
Division name
maxillofacial surgery
Zip code
Address
2-870-1 sakaecyo-nishi matudo city chiba
TEL
047-360-9395
Homepage URL
takahashi.kosuke@nihon-u.ac.jp
Sponsor or person
Institute
nihon university school of dentistry at matsudo
maxillofacial surgery
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 24 | Day |
Last modified on
| 2016 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015145
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
