UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044315 |
|---|---|
| Receipt number | 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 | 2022/12/01 18:51:43 |
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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
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
henmi@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Okitama Public General Hospital
Institute
Department
Personal name
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
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
64
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
No longer 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
| 2022 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049794
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
