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 UMIN000044315
Receipt No. R000049794
Scientific Title Analgesic effects of lidocaine ropivacaine mixture for extraction of impacted mandibular third molar: a randomized controlled trial
Date of disclosure of the study information 2021/06/01
Last modified on 2021/06/01

* 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 Analgesic effects of lidocaine ropivacaine mixture for extraction of impacted mandibular third molar: a randomized controlled trial
Acronym Analgesic effects of lidocaine ropivacaine mixture for extraction of impacted mandibular third molar
Scientific Title Analgesic effects of lidocaine ropivacaine mixture for extraction of impacted mandibular third molar: a randomized controlled trial
Scientific Title:Acronym Analgesic effects of lidocaine ropivacaine mixture for extraction of impacted mandibular third molar
Region
Japan

Condition
Condition impacted mandibular third molar
Classification by specialty
Anesthesiology Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we will perform conduction anesthesia using either lidocaine or a mixture of lidocaine and ropivacaine in patients undergoing extraction of mandibular impacted wisdom teeth. Onset and duration of the anesthetic effect will be measured. The anesthetics will be determined by random assignment. Blinding method is going to be performed. The purpose of this study is to investigate more effective anesthetics for extraction of mandibular embedded wisdom teeth.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Time from anesthesia to awareness of lower lip paresthesia
Key secondary outcomes Success rates, time from anesthesia to awareness of post-extraction pain, time to first analgesic use after extraction, NRS after extraction, complications after extraction

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 anesthesia with lidocaine
Interventions/Control_2 anesthesia with a mixture of lidocaine and ropivacaine
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatient undergoing extraction of mandibular implanted wisdom tooth
Key exclusion criteria history of hypersensitivity to anesthetics, paresthesia in the area of innervation of the mandibular nerve, active infection or abscess in the oral and maxillofacial region, bleeding diathesis, use of anticoagulant or antiplatelet medications, and other medical history that might have affected the clinical trial (eg, uncontrolled hypertension or diabetes mellitus, heart
failure, hyperthyroidism, psychiatric disorders)
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Tomoharu
Middle name
Last name Hemmi
Organization Okitama Public General Hospital
Division name dentistry, oral surgery
Zip code 9920601
Address 2000,nishi-otsuka, kawanisi, higashi-okitama, yamagata
TEL 0238465000
Email henmi@med.id.yamagata-u.ac.jp

Public contact
Name of contact person
1st name Tomoharu
Middle name
Last name Hemmi
Organization Okitama Public General Hospital
Division name dentistry, oral surgery
Zip code 9920601
Address 2000,nishi-otsuka, kawanisi, higashi-okitama, yamagata
TEL 0238465000
Homepage URL
Email henmi@med.id.yamagata-u.ac.jp

Sponsor
Institute Okitama Public General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Okitama Public General Hospital
Address 2000,nishi-otsuka, kawanishi, higashi-okitama, yamagata
Tel 0238465000
Email henmi@med.id.yamagata-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 234-1
Org. issuing International ID_1 Okitama Public General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 01 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
2021 Year 05 Month 01 Day
Date of IRB
2021 Year 02 Month 24 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2023 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 25 Day
Last modified on
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.