The aim of this study is the effect of injection with temperature of 37 ° C to reduce the pain caused by maxillary infiltration and compare it with inection at 21 ° C (room temperature) in the same person.
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an calculator.
Settings and conduct
The side of the jaw of the patients who are came to the Oral and Maxillofacial surgery department of Tehran Azad Dental University will be allocated by randomization method to the case and control groups. According to a pilot study, lidocaine cartridges were brought to a temperature of 40 by a heater. After one minute, which was the time to put the carpool and needle in the syringe, the carpool temperature reached 37 ° C, which will be injected on the case side. At the control side, the carpool will be injected at room temperature.
The study will be blinded. The person who is injected will not be aware of the tempreature of the injection. Immediately after injection, each person will be asked to express their pain levels from zero to one hundred, so that zero means no pain and one hundred means unbearable pain.
Participants/Inclusion and exclusion criteria
Individuals with ASA1 status whom do not have dental pain or infections in the maxillary premolar area and not taking NASIDS, benzodiazepins and antidepressants are the cases. they don't have lidocaine allergies and neuropathy
Intervention groups
Case group: side of the jaw of the patients whom are taking hot injections.
Control group: side of the jaw of the patients whom are taking room temperature.
Main outcome variables
Age, sex, Infection in the injection area; Dental pain in the injection area; Lidocaine allergy; Neuropathy; NSAID use; Benzodiazepine use; Antidepressant use; Pain intensity after injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190222042802N1
Registration date:2019-06-08, 1398/03/18
Registration timing:registered_while_recruiting
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Rayhaneh Pahlevan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
drrhpn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of heated local anesthetic on pain perception upon oral injection
Public title
Effect of heated local anesthetic on pain perception upon oral injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have American Society of Anesthesiologists 1 health status
Exclusion criteria:
Dental pain or infection at the puncture site
Not use nonsteroidal anti-inflammatory drugs in one week prior to study
Not use Banzodiasepines or anti-depressant drugs in the 2 months prior to the study
Neuropathy in facial area
Alergy to lidocaine
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
In each person 2 injections in each side of jaw
Randomization (investigator's opinion)
Randomized
Randomization description
The randomized method is a sequential or continuous referral to the Department of Dentistry's Department of Surgery.
Random unit: Individual
Randomization tool: The upper jaw of the referring people will be randomly assigned the RAN number calculator to select the first injection (cold or hot) on the dominant side of the referral.
According to the contract, if the given number is paired, a hot injection, and if the given number is one, cold injections will be performed on the dominant side (right or left).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the patient will not be aware of the temperature of the carpool; however the injectable person and reasurcher will be aware of the temperature by warming up the carpools and placing them in the syringe .
Placebo
Not used
Assignment
Parallel
Other design features
Split- mouth
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad University of Dental Science
Street address
No.9, Neyestan Ave., Pasdaran Blvd., Azad University of Dental Science
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.039
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
intensity of pain
Timepoint
immediately after injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection, on a randomly selected side, using a short needle of 30 gauges and a 0.9 ml volume of 1.8 ml carp after an aspiration at 0.15 ml / s will be administered. The bow needle to the bone and the needle needle size will be 2 mm. The injection site of Moucobacul Fold will be in the premolar area. In all injections, an Abslange will be used to remove soft tissue so that pain can not be relieved by pressure on the injection site. Lidocaine 2% cartridges containing 1: 100,000 epinephrine from the Daroo Pakhsh Company will be heated by the Tommee tippee heater of the UK at a temperature of 40 ° C. After one minute, the approximate time of insertion of the carpool and needle into the syringe is injected On the side of the case at 37 ° C (body temperature). These numbers are obtained for heating by conducting a pilot study
Category
Treatment - Surgery
2
Description
Control group: injection will be administered on contralateral side at room temperature.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehram Islamic Azad University of Dental Science
Full name of responsible person
Afshin Haragi
Street address
No. 9, Neyestan Ave., Pasdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Drhassani.omfs@gmail.com
Web page address
http://dental.iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No.9, Neyestan Ave., Pasdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 8805 3420
Email
drrhpn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Ali Hassani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
Drhassani.omfs@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Hassani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
Drhassani.omfs@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rayhaneh Pahlevan
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.9, Neyestan Ave., Pasdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 8805 3420
Email
Drrhpn@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study protocol, statistical analysis map, informed consent form, clinical study report, code used in the analysis and data dictionary will be shared and the personal information of the participants will not be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
All those who have access to the article can view the data.
Under which criteria data/document could be used
Use of data is strictly for reference in other articles.
From where data/document is obtainable
go to the Islamic Azad University Faculty of dental science on 9th Neyestan, Pasdaran Ave., or the author of the article, Reyhaneh Pahlavan, on 09129619673 and drrhpn@gmail.com.
What processes are involved for a request to access data/document
The claimant should visit the site where the article was published and enter it by name and specification of the article so that it can access the original text and information.