UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analgesic effects of Emla cream as topical anesthetic for gingiva.
Title of the study (Brief title)	Analgesic effects of Emla cream as topical anesthetic for gingiva.
Region	Japan

Condition
Condition	Dental medicine
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the analgesic effect of Emla cream applied to gingiva.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	I evaluate it by a change of Visual Analogue Scale, the vital signs after pricking gingiva with needle.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Emura group: Emura cream have applied 20 minutes before pucture with needle.
Interventions/Control_2	Ethyl aminobenzoate group: I puncture with a 25G needle after ethyl aminobenzoate have applied.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adults.
Key exclusion criteria	People who has paralysis on their faces. People who are allergic to local allergy.
Target sample size	30

Research contact person
Name of lead principal investigator	Tomoka Matsumura
Organization	Tokyo Medical and Dental University Dental Hospital.
Division name	Dental Anesthesiology
Address	1-5-45 Yushima Bunkyou-ku Tokyo Japan.
TEL	03-5803-5549
Email	tomoanph@tmd.ac.jp

Public contact
Name of contact person	Tomoka Matsumura
Organization	Tokyo Medical and Dental University Dental Hospital.
Division name	Dental Anesthesiology
Address	1-5-45 Yushima Bunkyou-ku Tokyo Japan.
TEL	03-5803-5549
Homepage URL
Email	tomoanph@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University Graduated school Anesthesiology and Clinical Physiology.
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 10 Day
Anticipated trial start date	2016 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 04 Month 25 Day
Last modified on	2017 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025418