Plain English Summary
Background and study aims
The use of local anesthesia in dental service causes immediate pain and discomfort during injection, causing many people to fear dental care. Previous reports, however, have suggested that heating the content of the anesthetic tube at a temperature between 37°C and 42°C results in significantly less pain. The aim of our research is to determine whether local anesthesia heated at 42°C causes less pain when administered compared to room temperature (21°C).
Who can participate?
Volunteer dental students for School of Dentistry of Austral University of Chile.
What does the study involve?
Each participant receives two local anesthesic injections. One side of the mouth is chosen at random to receive anesthesia warmed to 42 ° C. The other side receives anesthesia at room temperature (21°C). The two injections are administered by the same operator. Patients are then asked to describe their pain with reference to the Visual Analogue Scale VAS (0 = no pain, 10 = unbearable pain) immediately after each injection. Statistics are then used to analyse whether there is a significant difference in the amount of pain experienced.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Dental Emergency Service"Dr Jorge Sabat Gozalo"of Valdivia city (Chile)
When is the study starting and how long is it expected to run for?
April 2015 to June 2015
Who is funding the study?
Austral University of Chile
Who is the main contact?
Dr Pedro Aravena
Trial website
Contact information
Type
Scientific
Primary contact
Dr Pedro Aravena
ORCID ID
http://orcid.org/0000-0003-1230-4573
Contact details
Austral University of Chile (Universidad Austral de Chile)
Valdivia
5111434
Chile
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of temperature local dental anesthetics on injection pain: a split mouth study
Acronym
Study hypothesis
There is no differences between the level of perception of pain (Visual Analogue Scale - VAS) by increasing the temperature to 42 ºC in local anesthetic compared to its implementation at 21°C in patients of Dental Emergency Service of Valdivia city - Chile between April-June 2015.
Ethics approval
Ethical and Research Committee of Health Community Service of Valdivia, Chile, 16/03/2015, ref: 074/2915
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Perception of pain felt during dental procedures after administration of anesthesia
Intervention
In dental student volunteers, a dentist of Dental Emergency Service will administer in two points of the maxilla: One side with a 0,9 ml anesthesia ( 2% lidocaine with epinephrine 1: 100,000) in 42°C; and opposite side 0,9 ml of the same anesthetic in room temperature (21°C). Then, a researcher will show a Visual Analogue Scale with ten points (0=none pain to 10= unbearable pain) where the patient must indicate the intensity of perceived pain in the two points previously injected. The dentist and participants will be blind about the side of the injected site and the temperature of the cartridge anesthesia.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Independent Variable: 2 groups of cartridge anesthesia temperature: cartridge in 42°C and cartridge in temperature room (21°C)
2. Dependent Variable: Intensity pain level (VIsual Analogue Scale - VAS) from 0 point (no pain) to 10 points (unbearable pain)
Secondary outcome measures
N/A
Overall trial start date
01/04/2015
Overall trial end date
30/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Students over the age of 18
2. Given their informed consent
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
42
Total final enrolment
72
Participant exclusion criteria
1. Students with hypertension
2. Students with acute abscess or swelling at the injection site
Recruitment start date
01/06/2015
Recruitment end date
30/07/2015
Locations
Countries of recruitment
Chile
Trial participating centre
Dental Emergency Service "Dr Jorge Sabat Gozalo" of Valdivia city - Chile
2500, Picarte Street.
Valdivia
5111434
Chile
Funders
Funder type
University/education
Funder name
Austral University of Chile (Universidad Austral de Chile)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2018 results in https://pubmed.ncbi.nlm.nih.gov/29503582/ (added 01/09/2020)