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Register:	ISRCTN
Last refreshed on:	14 September 2020
Main ID:	ISRCTN78906795
Date of registration:	04/08/2015
Prospective Registration:	No
Primary sponsor:	Austral University of Chile (Universidad Austral de Chile)
Public title:	Effect of temperature local dental anesthetics on injection pain
Scientific title:	Effect of temperature local dental anesthetics on injection pain: a split mouth study
Date of first enrolment:	01/06/2015
Target sample size:	42
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN78906795
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Chile

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Pedro Aravena
Address:	Austral University of Chile (Universidad Austral de Chile) 5111434 Valdivia Chile
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Students over the age of 18
2. Given their informed consent

Exclusion criteria:
1. Students with hypertension
2. Students with acute abscess or swelling at the injection site

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Perception of pain felt during dental procedures after administration of anesthesia
Oral Health

Intervention(s)

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.

Primary Outcome(s)

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(s)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Austral University of Chile (Universidad Austral de Chile)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethical and Research Committee of Health Community Service of Valdivia, Chile, 16/03/2015, ref: 074/2915

Results

Results available:	Yes
Date Posted:
Date Completed:	30/06/2015
URL:

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