UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027380 |
|---|---|
| Receipt number | R000030213 |
| Scientific Title | The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2020/11/19 11:09:50 |
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Basic information
Public title
The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block
Acronym
The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block
Scientific Title
The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block
Scientific Title:Acronym
The study on the anesthetic range to the buccal nerve in inferior alveolar nerve block
Region
| Japan |
Condition
Condition
Oral surgical patients as indication for inferior alveolar nerve block
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the region of inferior alveolar nerve, buccal nerve,and lingual nerve using inferior alveolar nerve block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The anesthetic range of the buccal gingivaand buccal mucosa after inferior alveolar nerve block
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
One is mandible transmission anesthesia.
This way block the inferior alveolar nerve near the mandibular foramen.
Interventions/Control_2
The way is a local anesthetic is injected into the pterygomandibular space in front of the mandible.And, this can block the inferior alveolar nerve by diffusing backward and upward in pterygomandibular space.
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
1, patients who are indicated for lower alveolar neurotransmission anesthesia
2. Patients who need surgery for mandibular molars
3, patients who participated in clinical research at their own will and received written consent
Key exclusion criteria
1, Patients under 16 years old
2, patients with allergy and hypersensitivity to the drugs
3, Patients who already have paresthesia in the lower alveolar innervation area from preoperative
4, Other patients judged unsuitable by chief researchers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kindai university faculty of medicine
Division name
Department of anesthesiology
Zip code
5898511
Address
377-2,Ono-higashi,Osakasayama,Osaka
TEL
072-366-0221
hnghm1109@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kindai university faculty of medicine
Division name
Department of anesthesiology
Zip code
5898511
Address
377-2,Ono-higashi,Osakasayama,Osaka
TEL
072-366-0221
Homepage URL
hnghm1109@yahoo.co.jp
Sponsor or person
Institute
Kindai university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding and individual research expenses
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
Kindai university faculty of medicine of Ethics Committe
Address
377-2,Ono-higashi,Osakasayama,Osaka
Tel
072-366-0221
zizen@med.kindai.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
| 2017 | Year | 05 | Month | 22 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030213
| 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 |
