UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of the effect of flurbiprofen axetil and acetaminophen on preemptive analgesia
Title of the study (Brief title)	A Study of the effect of flurbiprofen axetil and acetaminophen on preemptive analgesia
Region	Japan

Condition
Condition	Missing teeth
Classification by specialty	Oral surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the effecacy of flurbiprofen axietil and acetaminophen on preemptive analgesia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	degree of pain after dental implant surgery
Key secondary outcomes	amount of oral analgesic agent after dental implant surgery and period until oral analgesic agent is taken

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	intravenous administration of normal saline before surgery
Interventions/Control_2	intravenous administration of flurbiprofen axetil before surgery
Interventions/Control_3	intravenous administration of acetaminophen before surgery
Interventions/Control_4	intravenous administration of flurbiprofen axetil and acetaminophen normal saline before surgery
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients scheduled for dental implant surgery
Key exclusion criteria	Patients with allergy for flurbiprofen axetil and/or acetaminophen Patient with aspirin-induced asthma
Target sample size	100

Research contact person
Name of lead principal investigator	Son Hiroki
Organization	Seishyukai clinic
Division name	Dentistry
Address	Kumata 1-4-20, Higashi sumiyoshi ku, Osaka
TEL	06-6713-9592
Email	mukr57217@iris.eonet.ne.jp

Public contact
Name of contact person	Hirata Yuya
Organization	Seishyukai clinic
Division name	Dentistry
Address	Kumata 1-4-20, Higashi sumiyoshi ku, Osaka
TEL	06-6713-9592
Homepage URL
Email	hiratayuya1981560224@yahoo.co.jp

Sponsor
Institute	Department of Dentistry, Seishyukai clinic
Institute
Department

Funding Source
Organization	Department of Dentistry, Seishyukai clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	青洲会診療所(大阪府)

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 27 Day
Anticipated trial start date	2015 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 12 Day
Last modified on	2017 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021595