Clinical trial on the assessment of the efficacy of the retromolar trigone injection technique as a supplementary anesthesia compared to conventional anesthesia on pain and bleeding during surgery in patients undergoing mandibular molar surgery
Determining the effectiveness of the retromolar injection technique as supplementary anesthesia in mandibular molar surgery in patients with retromolar foramina
Design
A controlled, double-blind, parallel-group clinical trial of 56 patients, randomized using an online program at sealedenvelope.com
Settings and conduct
The study is conducted on 56 samples from candidates for third molar surgery who referred to the surgery department of the Faculty of Dentistry of Qom University of Medical Sciences and the dental department of Fatemieh (Salamat) Clinic in Qom. The level of pain is asked by a non-surgeon, who is not aware of the type of anesthesia, using the VAS questionnaire for the purpose of blinding. The study will be conducted in a double-blind manner and the patient will not be aware of the type of anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
surgical candidates for extraction of mandibular molars; Identification of retromolar canal in panoramic or CBCT.
Exclusion criteria:
history of mandibular fracture; history of surgical removal of the mandibular third molar; history of mandibular orthognathic surgery; pathological lesion or osteomyelitis in the mandibular ramus, angle and proximal part of the mandibular body
Intervention groups
The intervention group: lower mandibular nerve block injection, long buccal nerve injection and injection in the retromolar area.
Control group: lower mandibular nerve and long buccal nerve block injection.
Main outcome variables
Pain during mucoperiosteal flap incision, pain during mucoperiosteal flap elevation, pain during osteotomy, pain during tooth extraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240205060911N1
Registration date:2024-07-30, 1403/05/09
Registration timing:prospective
Last update:2024-07-30, 1403/05/09
Update count:0
Registration date
2024-07-30, 1403/05/09
Registrant information
Name
Amir hossein Asgharnezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4242 2224
Email address
hasgharnezhad@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on the assessment of the efficacy of the retromolar trigone injection technique as a supplementary anesthesia compared to conventional anesthesia on pain and bleeding during surgery in patients undergoing mandibular molar surgery
Public title
Effectiveness of retromolar trigon injection as supplementary anesthesia in mandibular molar surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are surgical candidates for extraction of mandibular molars
Identification of retromolar canal in panoramic or CBCT
Exclusion criteria:
Mandibular fracture
Surgical removal of the mandibular third molar
Mandibular orthognathic surgery
Pathological lesion or osteomyelitis in the mandibular ramus, angle and proximal part of the mandibular body
Osteoradionecrosis and history of radiotherapy
Central or peripheral pathological lesion removal in the mandibular ramus, angle or proximal part of the mandibular body
Medical disorders including neurovascular system and mental disorders
Surgery under anesthesia and sedation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be unaware of their assignment to either the intervention or control group. For the purpose of blinding, a non-surgeon who is not aware of the type of anesthesia will ask and record the pain level of the patient using the VAS questionnaire. The study will be conducted in a double-blind manner and the patient will not be aware of the type of anesthesia.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Educational complex of Qom University of Medical Sciences, Shahid Lavasani Sahili
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2024-05-19, 1403/02/30
Ethics committee reference number
IR.MUQ.REC.1403.079
Health conditions studied
1
Description of health condition studied
The presence of anatomical variables of retromolar foramen and retromolar canal
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain level during incision of mucoperiosteal flap in patients with retromolar injection and patients without retromolar injection
Timepoint
5 minutes after the anesthesia intervention
Method of measurement
Visual Analogue Scale questionnaire
2
Description
Pain level when lifting the mucoperiosteal flap in patients with retromolar injection and patients without retromolar injection
Timepoint
5 minutes after the anesthesia intervention
Method of measurement
Visual Analogue Scale questionnaire
3
Description
Pain level during osteotomy in patients with retromolar injection and patients without retromolar injection
Timepoint
5 minutes after the anesthesia intervention
Method of measurement
Visual Analogue Scale questionnaire
4
Description
Pain level during tooth elevation in patients with retromolar injection and patients without retromolar injection
Timepoint
5 minutes after the anesthesia intervention
Method of measurement
Visual Analogue Scale questionnaire
Secondary outcomes
1
Description
Observation of gentle and diffus hemorrhage from the socket during surgical intervention (oozing)
Timepoint
After beginning of the intervention
Method of measurement
Observational
Intervention groups
1
Description
Intervention group: 1.5 mL lidocaine injection is administered for inferior alveolar nerve block using the direct technique. After 5 minutes, a 0.3 mL of long buccal nerve infiltration is injected in the distal vestibule of the furthest tooth with 0.2 mL of lidocaine infiltration in the retromolar area
Category
Treatment - Other
2
Description
Control group: 1.5 mL lidocaine injection is administered for inferior alveolar nerve block using the direct technique. After 5 minutes, a 0.3 mL of long buccal nerve infiltration is injected in the distal vestibule of the furthest tooth
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Qom University of Medical Sciences
Full name of responsible person
Ashkan Badkoobeh
Street address
Faculty of Dentistry, Shahid Lavasani street
City
Qom
Province
Ghoum
Postal code
3936737136
Phone
+98 25 3771 5212
Email
dens@muq.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr.Rahim Aali
Street address
No. 83, Shahid Lotfi Niaser alley, Jahade-Daneshhai alley, Safashehr street
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 2720
Email
research@mail.muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Amir hosein Asgharnezhad
Position
intern student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Andisheh dormitory complex, first branch, Shahid Karimi Blvd., Mofid Square,
City
Qom
Province
Ghoum
Postal code
3713174753
Phone
+98 25 3270 5319
Email
hasgharnezhad@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Amir Hosein Asgharnezhad
Position
intern student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Andisheh dormitory complex, first branch, at the beginning of Shahid Karimi Blvd, Mofid Square
City
Qom
Province
Ghoum
Postal code
3713174753
Phone
+98 25 3270 5319
Email
hasgharnejad@muq.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Amir hosein asgharnezhad
Position
intern student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Andisheh dormitory complex, first branch, at the beginning of Shahid Karimi Blvd, Mofid Square
City
Qom
Province
Ghoum
Postal code
3713174753
Phone
+98 25 3270 5319
Email
hasgharnejad@muq.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institution
Under which criteria data/document could be used
The request should clearly specify the purpose and type of data required.
Using data for statistical analysis that does not reveal individual identity.
Use of data for modeling and prediction without personal identification
Using data for scientific research
From where data/document is obtainable
Applicants can contact Amir Hossein Asgharanjad by phone number 00989117980678
Or contact the email address hasgharnezhad@muq.ac.ir.
Address: Qom, Mofid Square, Shahid Karimi Blvd., First Branch, Andisheh Hostel
What processes are involved for a request to access data/document
Submit a formal application,
The request must include a detailed description of the purpose of using the data,
The type of data needed and the reason for needing them should be mentioned.
Reviewing requests and confirming them after ensuring de-identification of data
The applicant must sign an agreement in which the commitment to keep the data confidential and to use them only for the specified purposes.
Secure delivery of data to prevent any unauthorized access.
The applicant must provide periodic reports on how the data is used.