Comparison of two needle tip designs, Sebtoject and NOP, on pain perception during inferior alveolar nerve block injections in 6 to 8 years old children
1. Determination and comparison the participants' characteristics (age, gender, rating of infant birth) in group AB & BA.
2. Determination and comparison the pain average based on face scale when injecting septoject and NOP in 6 to 8 infants.
3. Determination and comparison the pain average based on SME scale, when injecting block inferior nerve, between septoject and NOP in 6 to 8 infants.
4. Determinate the correlation between SME and face scale in 6 to 8 infants.
Design
The population of this study in the first period, randomly were divided in 2 equal groups and for this purpose we used of permuted block randomization method. The permuted block randomization was downloaded from http://randomization.com freely.
1. AB_____
2. AB_____
3. BA_____
4. BA_____
5. BA_____
6. AB_____
7. AB_____
8. BA_____
9. BA_____
10. AB____
11. BA____
...
30
Settings and conduct
This study is performed as a cross-sectional clinical trial in children aged 6 to 8 years referred to one of the pediatric dental treatment centers in Bushehr in 2020-2021.
Participants/Inclusion and exclusion criteria
Informing parents and gaining informed consent to participate in the study
Children are 6 to 8 years old
The patient has two stages of treatment (visit twice)
Intervention groups
Common septoject needle intervention (intervention A)
NOP needle intervention (intervention B)
Main outcome variables
The amount of pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210720051947N1
Registration date:2021-08-22, 1400/05/31
Registration timing:retrospective
Last update:2021-08-22, 1400/05/31
Update count:0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Sima Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 3226
Email address
s.jokar@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two needle tip designs, Sebtoject and NOP, on pain perception during inferior alveolar nerve block injections in 6 to 8 years old children
Public title
Comparison of two needle tip designs ,Sebtoject and NOP on pain perception during injections
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Informing parents and gaining informed consent to participate in the study
Children are 6 to 8 years old
The patient has two stages of treatment (visit twice)
Exclusion criteria:
Withdrawal from the study
History of allergy to anesthetic solution or contraindication to anesthesia
History of systemic diseases or special conditions that endanger public health
Taking painkillers in the last two months
Age
From 6 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
This study is two period cross over clinical trail. Based on this study the patients were presented in 2 frequency, 2 periods and 2 symbols, BA & AB.
In AB group, the first period ( A intervention) received septoject intervention and the second one (B intervention) received NOP intervention.
But in BA group right inverse the former, we observe in the first period NOP intervention and in the second one septoject intervention for injecting the analgesia medicine. The population of this study in the first period, randomly were divided in 2 equal groups and for this purpose we used of permuted block randomization method. The permuted block randomization was downloaded from http://randomization.com freely.
Blinding (investigator's opinion)
Double blinded
Blinding description
The population of the study randomly was divided in 2 equal group, A & B. Group A in the first visit received septoject needle and in the second one, NOP needle for injecting the analgesia medicine. Group B right inverse, patients in the first visit received NOP needle and in the second section, septoject for injecting the analgesia medicine ( cross design A&B). It is better to mention that just the dentist knows the order of permuted block randomization and participants' arrival; so evaluator should not observe the kind of intervention and the scale of block.
We can say that attribution of data will be hidden until the end of study.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Rishehr, Bandar Bushehr, Bushehr province
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2021-03-07, 1399/12/17
Ethics committee reference number
IR.BPUMS.REC.1399.195
Health conditions studied
1
Description of health condition studied
Inferior alveolar nerve block injections
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity score
Timepoint
Measurements immediately after the first and second injections
Method of measurement
1: Face criterion 2: Objective evaluation with SEM scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the group of patients that receive NOP. This needle is made in South Korea and because of silicone cover beside trihedral needle's top, cause less bleeding and trauma or even eliminate it during injection.
Category
Treatment - Devices
2
Description
Control group: the group receive sebtoject needle.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal office of Dr. Sima Jokar
Full name of responsible person
Dr. Sima Jokar
Street address
Emam Khomeini
City
Bushehr
Province
Boushehr
Postal code
7515735336
Phone
+98 77 3462 2515
Email
s.jokar@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Bushehr University Of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 1455 2247
Fax
+98 77 1455 2247
Email
Ghr.Khamisi@Gmail.Com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Sima Jokar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bushehr University of Medical Sciences., Bushehr ., bushehr province
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 3226
Fax
Email
s.jokar@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Sima Jokar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bushehr University of Medical Sciences., Bushehr ., bushehr province
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 3226
Fax
Email
s.jokar@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Sima Jokar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bushehr University of Medical Sciences., Bushehr ., bushehr province
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3332 3226
Fax
Email
s.jokar@bpums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available