Effect of temperature local dental anesthetics on injection pain
| ISRCTN | ISRCTN78906795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78906795 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/03/2015
- Registration date
- 04/08/2015
- Last edited
- 01/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Austral University of Chile (Universidad Austral de Chile)
Valdivia
5111434
Chile
 ORCID ID |
0000-0003-1230-4573 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effect of temperature local dental anesthetics on injection pain: a split mouth study |
| Study objectives | 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(s) | Ethical and Research Committee of Health Community Service of Valdivia, Chile, 16/03/2015, ref: 074/2915 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2015 |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 42 |
| Total final enrolment | 72 |
| Key inclusion criteria | 1. Students over the age of 18 2. Given their informed consent |
| Key exclusion criteria | 1. Students with hypertension 2. Students with acute abscess or swelling at the injection site |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 30/07/2015 |
Locations
Countries of recruitment
- Chile
Study participating centre
Valdivia
5111434
Chile
Sponsor information
University/education
Campus Isla Teja S/N.
Valdivia
5111434
Chile
"ROR" |
https://ror.org/029ycp228 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/02/2018 | 01/09/2020 | Yes | No |
Editorial Notes
01/09/2020: Publication reference and total final enrolment number added.
