UMIN-CTR Clinical Trial

Basic information
Public title	Study of pain control for dental treatment by the density of diphenhydramine difference
Acronym	Study of pain control for dental treatment by diphenhydramine
Scientific Title	Study of pain control for dental treatment by the density of diphenhydramine difference
Scientific Title:Acronym	Study of pain control for dental treatment by diphenhydramine
Region	Japan

Condition
Condition	Teeth are free of caries, large restrations, and periodontal disease
Classification by specialty	Anesthesiology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	it is said an emergency visit for the laceration that a patient having an allergic history can treat by minor operation for local anesthetic when the diphenhydramine 1% solution is effective as substitute medicine of the local anesthetic. We search the level whether analgesic effect is obtained by diphenhydramine when a patient having a history of the allergic reaction to local anesthetics undergoes dental treatment to require local anesthesia by this study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Confirmation of the anesthetic effect using a pulp tester 2)Time to analgesia manifestation 3)Duration of the analgesia 4)Circulatory dynamics 5)Presence and degree of the side effect manifestation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group D1 1.8mL of 1% difhenhydramine with 1:100,000 adrenarine
Interventions/Control_2	Group D1.5 1.8mL of 1.5% difhenhydramine with 1:100,000 adrenarine
Interventions/Control_3	Group D2 1.8mL of 2% difhenhydramine with 1:100,000 adrenarine
Interventions/Control_4	Group D1 1.8mL of 2% lidocaine with 1:100,000 adrenarine
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1. Written informed concent
Key exclusion criteria	1. The patient who has allergia to medicine to use in this examination 2.Pregnancy
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kimito Middle name Last name SANO
Organization	The Nippon Dental University achool of lifr Dentistry at Niigata
Division name	Department of Dental Anesthesia
Zip code	9518580
Address	1-8 Hamaura-cho, Chuo-ku, Niigata 951-8580,Japan
TEL	025-267-1500
Email	yamada@ngt.ndu.ac.jp

Public contact
Name of contact person	1st name Nozomi Middle name Last name YAMADA
Organization	The Nippon Dental University achool of lifr Dentistry at Niigata
Division name	Department of Dental Anesthesia
Zip code	9518580
Address	1-8 Hamaura-cho, Chuo-ku, Niigata 951-8580,Japan
TEL	025-267-1500
Homepage URL
Email	yamada@ngt.ndu.ac.jp

Sponsor
Institute	The Nippon Dental University achool of lifr Dentistry at Niigata
Institute
Department

Funding Source
Organization	Self funding
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	The Nippon Dental University achool of lifr Dentistry at Niigata
Address	1-8 Hamaura-cho, Chuo-ku, Niigata 951-8580,Japan
Tel	0252671500
Email	yamada@ngt.ndu.ac.jp

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	日本歯科大学新潟病院

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 15 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	Preinitiation
Date of protocol fixation	2011 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2013 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 02 Month 10 Day
Last modified on	2022 Year 02 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005892