Injection of local anesthesia is one of the most frightening and anxiety inducing
stimuli in dental practice. Many methods have been introduced to reduction of pain during injection of local anesthesia.
Computed controlled automatic anesthesia delivery system(Smartject) is one of the methods that is introduced for treatment of pain. It is one of the several non pharmacological techniques that is used to reduction of pain.Due to the limited data available on the use of Smartject in dentistry so, we have designed a randomized clinical trail study to compare Smartejct and conventional injection technique for pain control during anesthetic injection in dental patients.
The present study is a randomized clinical trial. The subjects consist of 50 volunteer dental students aged 23-28 years (boy and girl), studying in dental school of Shiraz University of Medical Sciences.
Exclusion criteria:
Subjects with history of systemic disease; Subjects with abscess, redness or fistula in injection site.
The Split mouth design is applied in the current study.
Base on black randomization table all of the participants will be assigned to receive anesthetic gel and Smartject (Korea) on one side of maxillary premolar buccal mucosa and anesthetic gel and conventional injection technique on other side of maxillary premolar buccal mucosa.
The dentist will record pain perception due to injection in both groups based on VAS (Visual Analogue Scale) and SEM scale (Sounds, Eye signs and Body Movement) .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101024445N2
Registration date:2016-03-24, 1395/01/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-24, 1395/01/05
Registrant information
Name
Mahboobe Ahmadbeigi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 4866
Email address
ahmadbeigim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparative evaluation of pain perception during anesthetic injection by Smartject and conventional technique
Public title
Comparative evaluation of pain perception during anesthetic injection by Computed controlled automatic anesthesia delivery system and conventional technique
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:
Subjects with history of systemic disease; Subjects with abscess, redness or fistula in injection site
Age
From 23 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The Split mouth design is applied in the current study.
Base on Black randomization table all of the participants w
ill be assigned to receive anesthetic gel and Smartject( Korea) on one side of maxillary premolar buccal mucosa and anesthetic gel and conventional injection technique on other side of maxillary premolar buccal mucosa.
Factors influencing health status and contact with health services
Primary outcomes
1
Description
Effect of Smartject on pain perception during injection
Timepoint
Immediately after intervention
Method of measurement
VAS (Visual Analogue Scale) and SEM scale (Sounds,Eye signs and Body Movement)
Secondary outcomes
empty
Intervention groups
1
Description
All of the participants will be assigned to receive anesthetic gel on one side of maxillary premolar buccal mucosa(intervention) then injection will be performed by Smartject (Korea). (intervention)
Category
Treatment - Drugs
2
Description
All of the participants will be assigned to receive anesthetic gel on other side of maxillary premolar buccal mocusa then conventional injection will be performed. (control)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences, School of Dentistry
Full name of responsible person
Mahboobe Ahmadbeigi
Street address
Department of Pediatric, School of Dentistry. Ghom abad, Ghasrodasht street,Shiraz, Fars, Iran