UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043137 |
|---|---|
| Receipt number | R000049249 |
| Scientific Title | Comparison of anesthetic area in buccal nerve block with different injection sites |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2023/07/31 09:32:05 |
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Basic information
Public title
Comparison of anesthetic area in buccal nerve block with different injection sites
Acronym
Anesthetic area in buccal nerve block
Scientific Title
Comparison of anesthetic area in buccal nerve block with different injection sites
Scientific Title:Acronym
Anesthetic area in buccal nerve block
Region
| Japan |
Condition
Condition
Mandibular tooth missing and oral maxillofacial
surgery for mandibular
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anesthetic area in the conventional buccal nerve block injecting local anesthetic at the mucous membrane of the anterior border of the ramus in
line with the occlusive plane never cross the
hight of parotid papilla. The aim of this study is
to examine if buccal nerve block with higher
injection position could across the the hight of
parotid papilla.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain response against pain stimulation at at the mucous membrane of the upper mucobuccal
fold
Key secondary outcomes
Anesthesia area of buccal nerve block
Pain response following the needle puncture for
infiltration anesthesia at buccal gingiva
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Conventional buccal nerve block
Interventions/Control_2
Buccal nerve block with higher injection position
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
1.Patients who are scheduled to undergo dental treatment, dental implant or oral surgery with invasion at lower buccal gingiva or cheek mucosa.
2.Patients agrees the purpose of this research
and participate voluntarily.
Key exclusion criteria
1.Patients with allergies or hypersensitivity
drugs to use
2.Patients who refuse to receive the buccal
nerve block
3.Patients who represent preoperative
paresthesia
4.Patients whom the lead principal investigator
judges as inappropriate
Target sample size
100
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 at Tokyo
Division name
Dental Anesthesiology
Zip code
102-8157
Address
1-9-20 Fujimi Chiyoda 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 at Tokyo
Division name
Dental Anesthesiology
Zip code
102-8157
Address
1-9-20 Fujimi Chiyoda 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
Self funding
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 Chiyoda 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
| 2021 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.joms.org/article/S0278-2391(22)01053-9/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.joms.org/article/S0278-2391(22)01053-9/fulltext
Number of participants that the trial has enrolled
38
Results
The effective tactile sensory loss rate at 5 mm above the height of the papilla of the parotid duct of the premolar and molar regions were greater following BNTB (71 and 95%, respectively) than following conventional BNB (37%: p<.01 and 58%; p,.01, respectively).
The proportions of intraoperative pain perception of the BNTB group and the conventional BNB group were 10 and 42%(p=.06), respectively, and those of supplemental infiltration anesthesia ere 5 and 26% (p=.18), respectively.
Results date posted
| 2023 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The clinical study was performed at the Outpatient Clinic of the Division of Oral Implantology, the Nippon Dental University Hospital from September 8, 2021 to March 20, 2022.
The study population for the clinical trial included patients, aged 18 years or older, who had been scheduled for removal of a mandibular third molar.
Participant flow
Exclusion criteria were a history of hypersensitivity to lidocaine, paresthesia of the buccal gingiva and buccal mucosa, 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).
Adverse events
There were no adverse events.
Outcome measures
The primary predictor variable was the approach for BNB (BNTB vs conventional BNB).
The primary outcome variable of interest was the extent of sensory loss of the buccal mucosa.
The secondary outcome variables were the anesthesia success rate of the
IANB for removal of third molars, and onset time and duration of BNBs.
The other study variables were age, sex, and injection side.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049249
