UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056686 |
|---|---|
| Receipt number | R000064793 |
| Scientific Title | Comparison of Local Anesthetic Effects of Articaine Hydrochloride and Lidocaine Hydrochloride |
| Date of disclosure of the study information | 2025/01/21 |
| Last modified on | 2025/01/10 18:11:10 |
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Basic information
Public title
Comparison of Local Anesthetic Effects of Articaine Hydrochloride and Lidocaine Hydrochloride for mandibular wisdom tooth extraction
Acronym
Comparison of Local Anesthetic Effects of Articaine Hydrochloride and Lidocaine Hydrochloride for mandibular wisdom tooth extraction
Scientific Title
Comparison of Local Anesthetic Effects of Articaine Hydrochloride and Lidocaine Hydrochloride
Scientific Title:Acronym
Comparison of Local Anesthetic Effects of Articaine Hydrochloride and Lidocaine Hydrochloride
Region
| Japan |
Condition
Condition
mandibular impacted wisdom tooth
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are three types of amide-type dental local anesthetics that can be used in Japan: lidocaine hydrochloride, propitocaine hydrochloride, and mepivacaine hydrochloride.Despite its frequent use in dental practice for analgesia, there has been little progress since the approval of dental mepivacaine formulations in 2002.
The alticaine hydrochloride used in this study is an amide-type local anesthetic, but because it contains an ester bond in its structural formula, about 90% is rapidly metabolized by non-specific esterases in the blood, and it is hardly metabolized in the liver as seen in other amide-type local anesthetics.In addition, articaine hydrochloride is the only local anesthetic that has a thiophene ring instead of a benzene ring, and since it has this thiophene ring, it is also advantageous that the fat solubility is further improved and the duration of the local anesthetic is improved.Articaine hydrochloride formulations were first introduced in Germany in 1976, introduced in Canada in 1983, and in the United States in 2000, making it a very common dental local anesthetic formulation in Europe and the United States.In Japan, it will be listed in the NHI on November 20, 2024, and will be launched on January 21, 2025.
Based on the above, the purpose of this study was to compare the changes in vital signs and the amount of local anesthetic and postoperative analgesic used during mandibular wisdom tooth extraction between local anesthesia with articaine hydrochloride and conventional local anesthesia with lidocaine hydrochloride.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Total amount of local anesthesia administered (mL)
(2) VAS evaluation during tooth extraction
(3) Surgery time
(4) Pell-Gregory classification
(5) Duration of local anesthetic
(6) Start time and amount of postoperative analgesics
(7) Adverse events
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
Articaine group: 2/90,000 adrenergic 4% articaine hydrochloride (3.4~5.1mL)
In 1 tube (1.7 mL), alticaine hydrochloride 68 mg, adrenergic hydrogen tartrate 0.031 mg
Interventions/Control_2
Lidocaine group: 1/80,000 adrenaline-supplemented 2% lidocaine salt (3.6~5,4mL)
In 1 tube (1.8 mL), lidocaine hydrochloride 36 mg, adrenergic hydrogen tartrate 0.045 mg
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Among the patients who are scheduled to have mandibular wisdom tooth extraction under local anesthesia at the 2nd floor oral surgery outpatient department of Tsurumi University Hospital, patients aged 18 to 80 years old who have obtained consent are eligible. In addition, patients up to ASAPS2.
Key exclusion criteria
ASAPS3 or higher, psychiatric disorders (patients taking psychotropic drugs, etc.), smokers, patients with a history of hypersensitivity to amide-type local anesthetics, and patients allergic to loxoprofen sodium and amoxicillin hydrate used postoperatively
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | Fujii |
| Last name | Abe |
Organization
Tsurumi University
Division name
Dental Anesthesiology
Zip code
2308501
Address
2-1-3, Tsurumi, Tsurumi-ku, Yokohama
TEL
0455130853
fujii-keiko@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | Fujii |
| Last name | Abe |
Organization
Tsurumi University
Division name
Dental Anesthesiology
Zip code
2308501
Address
2-1-3 Tsurumi, Tsurumi-ku
TEL
0455808343
Homepage URL
fujii-keiko@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Tsurumi University
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
tsurumi University
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama
Tel
0455808343
fujii-keiko@tsurumi-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 21 | 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
| 2025 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 01 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064793
