Determining the influence of Lidocaine temperature change on injection pain and analgesia success in maxillary central incisors
Design
A crossover double blinded randomized clinical trial on 100 volunteer, Random digit table will be used for randomization
Settings and conduct
In a crossover study injection pain and anesthesia success rate will be evaluated at the Endodontic Department of Kerman Dental School. Three different persons will be participated.The volunteers, the injector, the researcher who will be responsible for evaluating the tooth response to the electric pulp tester. In each stage, the pain during injection and the success rate of anesthesia were evaluated in two intervention groups: 1- temperature of 37 ° and intervention 2-with room temperature. Injection pain will be evaluated with visual analogue scale and anesthesia success will be evaluated with electric pulp tester.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age more than 18 years, no contraindications to injecting Lidocaine with Epinephrine, having no systemic disease, do not taking narcotic drugs or analgesic drugs in recent 48 hours before the study.
Exclusion criteria: Root canal treated teeth, open apex teeth, presence of periapical lesion
Intervention groups
Intervention 1: Injection single dose of Lidocaine 2% with Epinephrine 1:80000 (Iran, Tehran, Darupakhsh) at 37 C temperature
Intervention 2: Injection single dose of Lidocaine 2% with Epinephrine 1:80000 (Iran, Tehran, Darupakhsh) at room temperature
Main outcome variables
Injection pain, Anesthesia success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090609002016N10
Registration date:2018-10-13, 1397/07/21
Registration timing:prospective
Last update:2018-10-13, 1397/07/21
Update count:0
Registration date
2018-10-13, 1397/07/21
Registrant information
Name
Masoud Parirokh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1245 7931
Email address
m_parirokh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-08, 1397/08/17
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The influence of Lidocaine temperature change on injection pain and analgesia success in maxillary central incisors
Public title
Investigating the influence of temperature change of analgesia liquid on analgesia success
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
No consumption of analgesic and antidepressant medications during recent 48 hours
No contraindications or sensitivity for injecting lidocaine with epinephrine
Having no systemic disease
Exclusion criteria:
No response to the cold test
Having sensitivity to percussion
Having sensitivity to palpation
Previous history of root canal therapy
Internal or external resorption
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
2
Due to the cross-design of the study, the maxillary central incisors teeth of each person will be tested twice in this study this means that the anesthetic solution injected once at room temperature and two weeks later at 37 ° C (or vice versa).
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the volunteers are divided into Intervention 1 or Intervention 2 groups in crosswise manner, to determine the group to which the volunteers are assigned, the table of random numbers is used to extract some numbers. Numbers 1 to 10 are written on a piece of paper and the papers are folded. Each volunteer picks a paper, the odd numbers represent intervention 1 and the even numbers represent the intervention 2. Naturally, the second time (with a two week interval) receives a different intervention from the first series.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, three persons are kept blinded to the studied groups: 1. The injector, 2. The volunteer, 3. The person who evaluates the analgesia success after injection.
Blinding process of the injector: the fourth person has prepared analgesia liquids with different temperatures. These liquids are kept in syringes covered with paper wraps and are delivered to the injector so that he cannot understand the liquid temperatures.
Blinding process of the analgesia success evaluator: the person who evaluates the analgesia is different with the injector. the evaluator is not informed of the injected analgesia temperature. The pain caused by the injection is graded with a visual analogue scale (VAS), pain score from zero (no pain) to ten (severe pain) which is reported to evaluator by volunteer.
Blinding process of the volunteer: before the study, the volunteer is informed of the nature of the study, his blindness during the study, and his questions are answered. Each volunteer randomly picks a paper between 1 to 10 the odd numbers represent intervention 1 and the even numbers represent the intervention 2. The volunteers does not know the temperature of the analgesia liquid and their groups.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethic Committee of Kerman University of Medical Sciences
Street address
Vice-chancellor for Research, Building of Kerman University of Medical Sciences, Tahmaseb-abad cross, Jahad Street
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.KMU.REC.1396.2419
Health conditions studied
1
Description of health condition studied
Anesthesia injection pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain during injection
Timepoint
At the time of local anesthetic injection
Method of measurement
Using visual analoug scale (VAS)
2
Description
Success rate of anesthetic depth
Timepoint
After injection of local anesthesia
Method of measurement
Pulp tester
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Injection single dose of Lidocaine 2% with Epinephrine 1:80000 (Iran, Tehran, Darupakhsh) at 37 C temperature to 50 volunteer
Category
Treatment - Other
2
Description
Intervention group 2: Injection single dose of Lidocaine 2% with Epinephrine 1:80000 (Iran, Tehran, Darupakhsh) at room temperature to 50 volunteer
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic Department, Kerman Dental School
Full name of responsible person
Dr. Masoud Parirokh
Street address
School of Dentistry, Shafa street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 1245 7931
Email
masoudparirokh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.َ Abbas Pardakhti
Street address
Vice Chancellor for Research of Kerman University of Medical Sciences, Tahmsb Abbad Cross Raod, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 1245 7931
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Masoud Parirokh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shafa Street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 342118074
Fax
+98 34 1211 8073
Email
m_parirokh@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoud Parirokh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Headquarter Builidng of Kerman Medical Sciences University, Jomhori Eslami Bloubvared
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 1245 7931
Fax
+98 34 1211 8073
Email
m_parirokh@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sina Kakooei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Oral and Dental Research Center and Vice-Chancellor for Research, Kerman University of Medical Sciences, Shafa street
City
Kerman
Province
Kerman
Postal code
7618759554
Phone
+98 34 3211 3736
Email
s.kakooei@yahoo.com
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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available