- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05681546
Risk Factors of Inferior Alveolar Nerve Block Failure: a Dental Student-centered Study
September 17, 2024 updated by: Gokhan Gurses, Selcuk University
Inferior alveolar nerve block anesthesia is one of the most commonly used regional block anesthesia in dentistry.
The factors that determine the success of this type of anesthesia which is applied so frequently, are not reported in the literature.
It is to reveal and evaluate patient and dentist-based factors, especially in anesthesia applied by trainee dentists who have just learned this anesthesia block.
Study Overview
Status
Completed
Conditions
Detailed Description
In this study, the investigators are going to observe 200 IANB anesthesia in our clinic.
The investigators will evaluate the class, right/left handed, gender and experience on inferior alveolar nerve block of dental student.
The criteria the investigators will evaluate for the patient are as follows; gender, body mass index, ramus height, left/right side, and maximum mouth opening amount.
The criterion for the success of anesthesia are lost lip sensation within 10 minutes, no complication related to anesthesia.
Study Type
Observational
Enrollment (Actual)
340
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Konya
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Selçuklu, Konya, Turkey, 42250
- Selcuk University, Dentistry Faculty
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
In this study, the investigators are going to observe 320 IANB anesthesia in our clinic, which is the Oral and Maxillofacial Surgery Department of Selçuk University.
Description
Inclusion Criteria:
- having an indication of mandibular first or second molar extraction,
- being between 18 and 50 years old,
- not having any nerve or nerve-related disease,
- having a mouth opening 35 millimeters and above,
- not having an infected or inflamed tooth for extraction,
- being cooperative,
- non-allergic to articaine
- being right-handed (for dental-students)
- being intern (for dental-students)
Exclusion Criteria:
- anesthesia-related complications,
- more than twice the needed needle insertion
- wishing to quit the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Observational Group
The investigators are going to observe the risk factors about inferior alveolar nerve block anesthesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patrient-BMI index
Time Frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Ask the patrients their weight and height then note that as their bmi index.This note guides us amount of bichat and how it affects the failure of block anesthasia.
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after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Patrient-Height of mandibular ramus
Time Frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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measuring of mandibular ramus on panoromic radyography from mandibular angulus to condylar head.
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after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Patrient-Gender
Time Frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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attending patrients sex
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after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Patrient-Maximum mouth opening
Time Frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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before the anesthasia, make the patrients open their mouth maximum then measure it from lower incisors incisal edge to upper incisors incisal edge.
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after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Gender
Time Frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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attending dental studens sex
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after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Student-Class
Time Frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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attending dental students in which period for the explanation of their experiment level
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after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Dental student-Mandibular nerve block experience
Time Frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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attending dental students in which period for the explanation of their experiment level
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after 5 minutes, patrients come to our clinic and sit on the dental unit.
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which side for the mandibular block anesthasia
Time Frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Does the side of anesthesia according to the hand used affect its success?
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after 5 minutes, patrients come to our clinic and sit on the dental unit.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gökhan Gürses, Selcuk University, Faculty of Dentistry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thangavelu K, Kannan R, Kumar NS. Inferior alveolar nerve block: Alternative technique. Anesth Essays Res. 2012 Jan-Jun;6(1):53-7. doi: 10.4103/0259-1162.103375.
- Kohler BR, Castellon L, Laissle G. Gow-Gates technique: a pilot study for extraction procedures with clinical evaluation and review. Anesth Prog. 2008 Spring;55(1):2-8. doi: 10.2344/0003-3006(2008)55[2:GTAPSF]2.0.CO;2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2023
Primary Completion (Actual)
July 18, 2024
Study Completion (Actual)
September 17, 2024
Study Registration Dates
First Submitted
December 26, 2022
First Submitted That Met QC Criteria
December 26, 2022
First Posted (Actual)
January 12, 2023
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 17, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Selcuk03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.