Comparison of pain during inferior alveolar nerve block in conventional and two stage techniques (new modification).
Design
Clinical trial with two groups of 16 control (conventional technique) and intervention (double injection technique) in the age range of 20 to 60 years. With parallel, randomized, phase 2 groups on 32 patients. Excel software rand function was used for randomization. In this study, due to the nature of the intervention, it is not possible to blind the patient and the researcher.
Settings and conduct
Ask patient to sits on the dental unit and wait for 10 minutes till patient's heart rate be normalized. The vital sign device is connected to the patient to measure heart rate, blood pressure and respiratory rate, and the patient will be monitored. The injection is then performed in a conventional, two-stage manner in two groups (each group includes 16 people). The patient's vital signs are then monitored during the injection. Finally, the patient is asked to describe their pain using the NRS scale. The study is in the clinic of Sari Dental School.
Participants/Inclusion and exclusion criteria
Admission requirements: all people have a healthy systemic condition.
Conditions of not entering: all people with systemic diseases and the use of drugs that change the perception of pain.
Intervention groups
For the two-injection method, the ICT device is used at the highest speed. The patient's vital signs are then monitored during the injection. In the control group, the injection is performed in a conventional manner and at the end the patient is asked to describe his pain using the NRS scale.
Main outcome variables
Pain rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220106053646N1
Registration date:2022-02-17, 1400/11/28
Registration timing:prospective
Last update:2022-02-17, 1400/11/28
Update count:0
Registration date
2022-02-17, 1400/11/28
Registrant information
Name
Amirhossein Moaddabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3340 5474
Email address
s_bnf_s@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-05-21, 1401/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of Pain During Inferior Alveolar Nerve Block in Conventional and Two Stage Technique ( New Modification)
Public title
Comparsion of Pain During Inferior Alveolar Nerve Block in Conventional and Two Stage Technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people have healthy systemic conditions.
Exclusion criteria:
All people with heart and respiratory problems and high blood pressure
People taking medications that change their perception of pain, such as corticosteroids.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment of samples to two groups of 16, the blocking method will be used. For this purpose, six quadruple blocks will be considered. Six blocks are TCTC , TTCC, CTTC, CTCT, CCTT ,TCCT which T is for the intervention group and C is for the control group. The numbers will be generated randomly (with the RANDBETWEEN command in Excel software and in the range of 1 to 6).Depending on the production values, one of the blocks (for production number between 0 to 1 CTTC block, for production number between 1 to 2 CTCT blocks and so on) will be selected and samples will be assigned.
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Central Headquarters of Mazandaran University of Medical Science , at the beginning of Valiasr Highway , Joybar Three Ways, Imam Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.MAZUMS..REC.1400.12681
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain rate
Timepoint
At the end of the injection, the patient is asked to describe his or her pain using the NRS scale
Method of measurement
Using the NRS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Benzocaine surface anesthesia gel is applied using an applicator in the needle entry area. Anesthesia drug containing vasoconstrictor will be used for anesthesia injection. ICT Injection device is used in two-stage injection. Needle heads used in two sizes of 12 and 25 mm with 30 gauge of transcodent brand will be used for Inferior alveolar nerve block. In the first injection, we inject one third of the carpol with a 12 mm needle and after two minutes, we change the needle to 25 mm and inject two thirds of the carpol.
Category
Other
2
Description
Control group: Benzocaine surface anesthesia gel is applied using an applicator in the needle entry area. Anesthesia drug containing vasoconstrictor will be used for anesthesia injection . For the inferior alveolar nerve block in conventional injection, a 32 mm long needle with a 27 gauge from the Soha brand will be used.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Dental School Clinic
Full name of responsible person
Amir Hossein Moaddabi
Street address
Sari Dental School , next to Touba Medical Complex, Khazar Boulevard,Sari
City
Sari
Province
Mazandaran
Postal code
4816895476
Phone
+98 11 3324 4894
Email
m.moaddabi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid saeidi
Street address
Sari, Moallem Square, Vice Chancellor for Research, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein moaddabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sari Dental School , next to Touba Medical Complex, Khazar Boulevard,Sari
City
Sari
Province
Mazandaran
Postal code
4816895476
Phone
+98 11 3324 4894
Email
m.moaddabi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein moaddabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sari Dental School , next to Touba Medical Complex, Khazar Boulevard,Sari
City
Sari
Province
Mazandaran
Postal code
4816895476
Phone
+98 11 3324 4894
Email
m.moaddabi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Moaddabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sari Dental School , next to Touba Medical Complex, Khazar Boulevard,Sari
City
Sari
Province
Mazandaran
Postal code
4816895476
Phone
+98 11 3324 4894
Email
m.moaddabi@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants' files are private and cannot be shared.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Patient data includes age and sex and does not include private information.
When the data will become available and for how long
Start of access period 1 year after printing the results
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Documents and data can only be used for reference.
The data will be provided to the applicant in case of urgent need.
From where data/document is obtainable
To receive data, postal correspondence to Sari Dental School of Mazandaran Province at the address: next to Toobi Medical Complex of Dental School, Farahabad Boulevard,Khazar Square, Sari .
Postal code: 4816895476
Dr. Amir Hossein Modabi
What processes are involved for a request to access data/document
After receiving the postal letter, the reply letter will be corresponded to the listed address within a maximum of two weeks.