Anesthesia, LocalNCT05681546
Risk Factors of Inferior Alveolar Nerve Block Failure: a Dental Student-centered Study
An observational study of Anesthesia, Local, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- How many people
- 340 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2023to 17 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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,
Show all 9Show fewer
- non-allergic to articaine
- being right-handed (for dental-students)
- being intern (for dental-students)
Who cannot join
- anesthesia-related complications,
- more than twice the needed needle insertion
- wishing to quit the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Dentistry Faculty
Selçuklu, Konya, 42250
About this study
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.
Read the 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.
- Conditions
- Anesthesia, Local
- Keywords
- anesteshia failure, mandibular nerve, dental student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | The investigators are going to observe the risk factors about inferior alveolar nerve block anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patrient-BMI index
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.
Measured: after 5 minutes, patrients come to our clinic and sit on the dental unit.
Patrient-Height of mandibular ramus
measuring of mandibular ramus on panoromic radyography from mandibular angulus to condylar head.
Measured: after 5 minutes, patrients come to our clinic and sit on the dental unit.
Patrient-Gender
attending patrients sex
Measured: after 5 minutes, patrients come to our clinic and sit on the dental unit.
Patrient-Maximum mouth opening
before the anesthasia, make the patrients open their mouth maximum then measure it from lower incisors incisal edge to upper incisors incisal edge.
Measured: after 5 minutes, patrients come to our clinic and sit on the dental unit.
Gender
attending dental studens sex
Measured: after 5 minutes, patrients come to our clinic and sit on the dental unit.
Student-Class
attending dental students in which period for the explanation of their experiment level
Measured: after 5 minutes, patrients come to our clinic and sit on the dental unit.
Dental student-Mandibular nerve block experience
attending dental students in which period for the explanation of their experiment level
Measured: after 5 minutes, patrients come to our clinic and sit on the dental unit.
which side for the mandibular block anesthasia
Does the side of anesthesia according to the hand used affect its success?
Measured: after 5 minutes, patrients come to our clinic and sit on the dental unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start27 Feb 2023
- Primary completion18 Jul 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Gurses, Selcuk University
- Investigators
- Gökhan Gürses, Study chair, Selcuk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681546
- Sponsor's protocol ID
- Selcuk03
- Status last verified
- Sep 2024
- First submitted
- 26 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25885503Kohler 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.
PubMed 18327969
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Inferior Alveolar Nerve Block Failure: a Dental Student-centered Study
- ClinicalTrials.gov ID
- NCT05681546
- Acronym / sponsor ID
- Selcuk03
- Conditions
- Anesthesia, Local
- Keywords
- anesteshia failure, mandibular nerve, dental student
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | –The investigators are going to observe the risk factors about inferior alveolar nerve block anesthesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (3 listed)
- anesthesia-related complications,
- more than twice the needed needle insertion
- wishing to quit the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patrient-BMI index
Time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
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.
Patrient-Height of mandibular ramus
Time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
measuring of mandibular ramus on panoromic radyography from mandibular angulus to condylar head.
Patrient-Gender
Time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
attending patrients sex
Patrient-Maximum mouth opening
Time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
before the anesthasia, make the patrients open their mouth maximum then measure it from lower incisors incisal edge to upper incisors incisal edge.
Gender
Time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
attending dental studens sex
Student-Class
Time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
attending dental students in which period for the explanation of their experiment level
Dental student-Mandibular nerve block experience
Time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
attending dental students in which period for the explanation of their experiment level
which side for the mandibular block anesthasia
Time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.
Does the side of anesthesia according to the hand used affect its success?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 25885503Thangavelu 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.
- Results publication: PubMed 18327969Kohler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gökhan Gürses study chair
Selcuk University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patrient-BMI index (time frame: after 5 minutes, patrients come to our clinic and sit on the dental unit.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681546, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.