Comparison of pain and stress during dental treatment ofchildren usingpalatal anesthesia in trans papillary and computerized anesthesia methods
Design
This study is a clinical trial. In this study, 18 patients with children aged 5-8 years who are referred to the private office of Dr. Hamid Sarlak, a pediatric dentist in Arak, will be studied. This study is a clinical trial double-blind.
Settings and conduct
This study is a clinical trial. In this study, 18 patients with children aged 5-8 years who are referred to the private office of Dr. Hamid Sarlak, a pediatric dentist in Arak, will be studied. This study is a clinical trial double-blind.Outcome assessor and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Candidate for bilateral pulpotomy and SCC treatment in high molar molar teeth, lack of any unpleasant dental history, lack of systemic disease, absence of genetic disease
Exclusion criteria:Lack of cooperation
Intervention groups
In the first group, in the first session of the palatal injection of the trans-papillary (control) method, and in the second session, the injection was performed using a computer device (ICTinjection GENOSS, Gyeonggi-do, South Korea) (test).
In the second group, in the first session of treatment, palatal injection was performed using the ICTinjection computer (test) and in the second session, using a trans-papillary (control) method.
Main outcome variables
Pain, stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N101
Registration date:2019-04-06, 1398/01/17
Registration timing:registered_while_recruiting
Last update:2019-04-06, 1398/01/17
Update count:0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain and stress during dental treatment ofchildren usingpalatal anesthesia in trans papillary and computerized anesthesia methods
Public title
Comparison of pain and stress during dental treatment ofchildren usingpalatal anesthesia in trans papillary and computerized anesthesia methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for bilateral pulpotomy and SCC treatment in high molar molar teeth
Lack of any unpleasant dental history
Lack of Systemic Disease
Absence of genetic disease
Exclusion criteria:
Lack of cooperation
Age
From 5 years old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number in division of groups in two groups A and B.Randomized patients are divided into two groups.
The candidate patients who enter the study are randomly assigned to the randomly assigned table of randomly assigned to the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Outcome assessor and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.ARAKMU.REC.1397.287
Health conditions studied
1
Description of health condition studied
Bilateral pulpotomy
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
pain
Timepoint
While injecting anesthetics and during pulp exposure
Method of measurement
Faces Pain Rating Scale
2
Description
pain
Timepoint
While injecting anesthetics
Method of measurement
Sound Eye Motor Pain
3
Description
stress
Timepoint
While injecting anesthetics and during pulp exposure
Method of measurement
objective
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, in the first session of the palatal injection of the trans-papillary (control) method, and in the second session, the injection was performed using a computer device (ICTinjection GENOSS, Gyeonggi-do, South Korea) (test).
Category
Treatment - Devices
2
Description
Intervention group: In the second group, in the first session of treatment, palatal injection was performed using the ICTinjection computer (test) and in the second session, using a trans-papillary (control) method.