Evaluation of the Success of Inferior Alveolar Nerve Block and Long Buccal Nerve Block Techniques Compared to Simultaneous Intraosseous Injection and Local Infiltration in the Extraction of Mandibular Molars
Comparison of the Success Rate of Inferior Alveolar Nerve Block and Long Buccal Nerve Block Techniques with Simultaneous Intraosseous Injection and Local Infiltration in the Extraction of Mandibular Molars
Design
A clinical trial with two intervention groups and randomized parallel groups on 38 patients needing mandibular molar extraction, using balanced block randomization.
Settings and conduct
The study will include 38 patients needing extraction of posterior mandibular teeth at Alborz University of Medical Sciences. Participants will be divided into two groups: Group 1 will receive Inferior Alveolar Nerve Block and Long Buccal Injection, while Group 2 will undergo simultaneous Intraosseous Injection and Local Infiltration. Success will be evaluated based on the level of pain reported by the patient during the procedure.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients needing to have the posterior mandibular teeth extracted on both sides of the mouth
Exclusion Criteria:
Suffering from systemic diseases such as cardiovascular, neurological, and renal diseases
History of drug allergies (penicillin, codeine, and other anesthetic drugs)
Pregnant women
Addiction to drugs or alcohol
Patients with a history of medical conditions and those taking medications that affect anesthesia, such as neuropsychiatric drugs.
Intervention groups
Group 1: Conventional Inferior Alveolar Nerve Block and Long Buccal Injection,
Group 2: Simultaneous Infiltration and Intraosseous Injection
Main outcome variables
Success in Lower Jaw Anesthesia, Pain During Injection, and Pain During Tooth Extraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241111063673N1
Registration date:2024-12-23, 1403/10/03
Registration timing:prospective
Last update:2024-12-23, 1403/10/03
Update count:0
Registration date
2024-12-23, 1403/10/03
Registrant information
Name
Mohamma arsalan Ghavimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 435 7642
Email address
arsalanqavimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Success of Inferior Alveolar Nerve Block and Long Buccal Nerve Block Techniques Compared to Simultaneous Intraosseous Injection and Local Infiltration in the Extraction of Mandibular Molars
Public title
Anesthesia Techniques in the Extraction of Mandibular Molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients needing to have the posterior teeth of the mandible extracted on both sides of the mouth
Exclusion criteria:
Suffering from systemic diseases such as cardiovascular, neurological, and renal diseases
History of drug allergies (penicillin, codeine, and other anesthetic drugs)
Pregnant mothers.
Patients with a history of medical conditions and those taking medications that affect anesthesia, such as neuropsychiatric drugs
Addiction to drugs or alcohol.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
More than 1 sample in each individual
Number of samples in each individual:
2
Two posterior mandibular teeth on both sides of the mouth symmetrically
Randomization (investigator's opinion)
Randomized
Randomization description
The intervention allocation model in this study is balanced block randomization using four-block random blocks, which include four conditions (first right control/first right intervention/first left control/first left intervention). The randomization process is performed using Excel software. This process is conducted before the start of the study by the study methodology consultant, and none of the other researchers are aware of the allocation process. After random allocation, the type of allocation for each sample is placed in a sealed envelope, and the envelopes are numbered and opened during the treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Sciences
Street address
Karaj - 45 Metri Golshahr - Safarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2024-10-28, 1403/08/07
Ethics committee reference number
IR.ABZUMS.REC.1403.195
Health conditions studied
1
Description of health condition studied
Posterior Mandibular Teeth
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Success Rate of Lower Jaw Anesthesia
Timepoint
15 minutes after injection
Method of measurement
Questioning the Patient
Secondary outcomes
1
Description
Pain during injection
Timepoint
Immediately after injection
Method of measurement
Visual Analogue Scale
2
Description
Pain during tooth extraction
Timepoint
after tooth extraction
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group:Alveolar Nerve Block and Long Buccal Nerve Block Technique
Category
Treatment - Drugs
2
Description
Intervention group: Simultaneous Intraosseous Injection and Local Infiltration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Dental Clinic, Alborz Dental School
Full name of responsible person
Arezoo Agha Kuchakzadeh
Street address
Dental School, Ketouei Zadeh Square, 45th Meter Golshahr, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3353 1614
Email
dentalclinic@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Research and Technology Department, Safarian Alley, 45 Meter Golshahr, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Upon formal and reasonable request by researchers, the documentation related to each participant will be provided after the information has been anonymized
When the data will become available and for how long
Access will be available from the time of article publication.
To whom data/document is available
Researchers and clinical specialists.
Under which criteria data/document could be used
Data is accessible for research and clinical use.
From where data/document is obtainable
Applicants can access the data by sending an official request to the email arsalanqavimi@gmail.com.
What processes are involved for a request to access data/document
The request will be reviewed by the research team, and if approved, the documentation will be sent to the applicants.