UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042649 |
|---|---|
| Receipt number | R000048668 |
| Scientific Title | Multicenter study of anesthetic efficacy of inferior alveolar nerve block using anterior technique for pulpectomy of mandibular posterior teeth with irreversible pulpitis |
| Date of disclosure of the study information | 2020/12/04 |
| Last modified on | 2020/12/04 13:56:42 |
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Basic information
Public title
Anesthetic efficacy of anterior technique for pulpectomy of mandibular posterior teeth
Acronym
AAPM study
Scientific Title
Multicenter study of anesthetic efficacy of inferior alveolar nerve block using anterior technique for pulpectomy of mandibular posterior teeth with irreversible pulpitis
Scientific Title:Acronym
AAPM study
Region
| Japan |
Condition
Condition
irreversible pulpitis
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although Halsted method for inferior alveolar nerve block (conventional IAN block) has been recommended to relieve pain in patients with irreversible pulpitis, previous studies have shown success rates of only 19%-56% for conventional IAN blocks. The purpose of this multicenter open prospective study is to evaluate the anesthetic efficacy of anterior technique for inferior alveolar nerve block in patients with mandibular posterior teeth experiencing irreversible pulpitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain reaction during pulpectomy operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Two point seven ml of 1:80.000 epinephrine added 2% lidocaine administer before pulpectomy. One point eight ml of same anesthetics additional administer when can not anesthetic effect.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults over 20 years old who are having irreversible pulpitis and understand the purpose of this research and participate voluntarily.
Key exclusion criteria
1. Patients with allergies or hypersensitivity ths anesthetics to use
2. Patients who refuse to receive the anterior technique for inferior alveolar nerve block
3. Patients who request the infiltlation anesthesia for pulpectomy
4. Patients whom the lead principal investigator judges as inappropriate
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | katsuhisa |
| Middle name | |
| Last name | sunada |
Organization
The Nippon Dental University, school of Life Dentistry Tokyo
Division name
Dental Anesthesiology
Zip code
102-8157
Address
1-9-20 Fujimi Chiyodaku Tokyo
TEL
81-3-3261-6064
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | katsuhisa |
| Middle name | |
| Last name | sunada |
Organization
The Nippon Dental University, school of Life Dentistry Tokyo
Division name
Dental Anesthesiology
Zip code
102-8157
Address
1-9-20 Fujimi Chiyodaku Tokyo
TEL
81-3-3261-6064
Homepage URL
katsu.sunada@nifty.com
Sponsor or person
Institute
The Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental 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
IRB of NDU
Address
1-9-20 Fujimi Chiyodaku Tokyo
Tel
81-3-3261-8311
ndu-rinri@tky.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 04 | 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
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048668
| 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 |
