Condition category
Oral Health
Date applied
12/03/2015
Date assigned
04/08/2015
Last edited
20/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

Sponsor information

Organisation

Austral University of Chile (Universidad Austral de Chile)

Sponsor details

Campus Isla Teja S/N.
Valdivia
5111434
Chile

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes