UMIN-CTR Clinical Trial

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
Email	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
Email	Miya0331@me.com

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035086