UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030728
Receipt No. 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 2018/01/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Open public recruiting
Date of protocol fixation
2014 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 08 Day
Last modified on
2018 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.