UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030728 |
|---|---|
| Receipt number | R000035086 |
| Scientific Title | A pain-killing effect of Platelet Rich Fibrin after extraction of an impacted wisdom tooth |
| Date of disclosure of the study information | 2018/01/09 |
| Last modified on | 2020/07/13 10:24:14 |
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Basic information
Public title
A pain-killing effect of Platelet Rich Fibrin after extraction of an impacted wisdom tooth
Acronym
A pain-killing effect of Platelet Rich Fibrin after extraction of an impacted wisdom tooth
Scientific Title
A pain-killing effect of Platelet Rich Fibrin after extraction of an impacted wisdom tooth
Scientific Title:Acronym
A pain-killing effect of Platelet Rich Fibrin after extraction of an impacted wisdom tooth
Region
| Japan |
Condition
Condition
an impacted wisdom tooth
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine a pain-killing effect of PRF after extraction of an impacted tooth
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The decline rate of visual analog scale at seven days after extraction
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Insert PRF to extraction socket immediate after tooth extraction
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
1. The person who receives a consent for the documentary participation in this study.
Key exclusion criteria
1. Patients with any blood disease
2. When the VAS, the recording of the diary is impossible
3. Patients who regularly use analgesics
4. Patients who regularly use psychotropics
5. Pregnant women, lactating women, patients with the possibility of pregnancy
6. Patients with penicillin drug allergy
7. Patients with aspirin asthma
8. Infectious mononucleosis patients
9. Patinets with a history of peptic ulcer
10. The person whom a doctor disqualifyied for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aoki Naofumi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
(052)858-7302
nao70231011@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyamoto Hironori |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
(052)858-7302
Homepage URL
Miya0331@me.com
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 01 | Month | 09 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 08 | Day |
Last modified on
| 2020 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035086
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
