Protocol summary

Study aim
The aim of this study was to compare the amount of pain in injecting articular infiltration anesthesia in the mandibular buccal area in children aged 4 to 8 years using needles with confusion 27 and 30.
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 2 on 60 patients. To randomize in this study, SPSS software version 16 is used to place children in groups 1 or 2 based on the priority and delay of needle confusion in anesthesia injection. Also, 60 very similar envelopes were used in the third session to select the lower jaw quadrant, half of which is zero and the other half is one.
Settings and conduct
This study is a clinical trial (Split Mouth) and will be performed as a split on clients in the private office of a pediatric dentist. In this study, the samples are divided into two main groups. In the first group, first in the first session of treatment. First, a one-way (left or right) mandibular injection needle with 30 gauge needle will be used.
Participants/Inclusion and exclusion criteria
1. All specialists must have a candidate for the required functions who use bilateral pulpotomy and SCC in Mلller Dentistry. 2. Genetically, systematically and observing a healthy learner. 3. Due to the fact that we can have a distribution limit using a specialist doctor. 4. You can be positive (positive) or completely positive (definitely definitely positive) in terms of Frankl's cooperation criteria.
Intervention groups
For those who participated in this study, based on what was said in the implementation section, Bacal anesthesia injection was one of the 27 and 30 gauge needles in the first session of treatment on one side of the mandible and the needle with another gauge in the second session of treatment on the opposite side of the jaw will be done.
Main outcome variables
The outcome of all studies is to measure pain and anxiety.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200509047369N1
Registration date: 2020-05-21, 1399/03/01
Registration timing: prospective

Last update: 2020-05-21, 1399/03/01
Update count: 0
Registration date
2020-05-21, 1399/03/01
Registrant information
Name
Mohammad Najafi haghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3774 3096
Email address
dr.mohammad_najafi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effect of Needle Gauge on Pain and Anxiety of Children During Articaine Mandibular Buccal Infiltration Anesthesia
Public title
The Comparison of the Effect of Needle Gauge on Pain and Anxiety of Children During Articaine Mandibular Buccal Infiltration Anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients should be candidates for similar treatment for bilateral pulpotomy and SCC in the first molar teeth of the mandible They are genetically, systemically and capable of healthy learning They also have no history of dentistry and hospitalization. In terms of cooperation criteria, Frankel is in a positive or positive position.
Exclusion criteria:
Existence of servere pain or obvious need for treatment on a side earlier of opposite side that excludes the study from a random state.
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Teaching method: simple Decision Making Unit: Possibility Tools for providing services: To have a license in two groups based on demand and Thatcher Gage needle in the field of anesthesia injection using lottery and to select quadrant jaw in providing 60-person services, you can control half of the number once by using your normal resources. . Created by single and black envelopes 1: First consultation session: Gage needle 30 Second session: Gage needle 27 Group 2: First consultation session: Gage needle 27 Second session: Gage needle 30
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is of the three Socor type, as the patient, dentist, and statistical analyzer are unaware of how individuals are assigned to groups and the type of intervention performed at each session to treat individuals.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of arak University of Medical Sciences
Street address
Academic complex of the Payambar Azam, Basij squre, Sardasht
City
َArak
Province
Markazi
Postal code
3819693345
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.ARAKMU.REC.1399.025

Health conditions studied

1

Description of health condition studied
The Comparison of the Effect of Needle Gauge on Pain and Anxiety of Children During Articaine Mandibular Buccal Infiltration Anesthesia
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Pulse rate
Timepoint
The heart rate is measured three times in each treatment session (third and fourth sessions) and recorded by the dentist's assistant. 1. After the child sits on the unit (one minute before the injection) 2. 10 seconds after the start of the anesthesia injection Topical 3. At the time of pulp exposure.
Method of measurement
The OXY300 digital electronic device (microlife AG.widnau.swit Switzerland) will be used to check the heart rate by placing the probe on the index finger of the child's left hand.

2

Description
face pain rating
Timepoint
after injection of anesthesia
Method of measurement
Subjective measurement of pain is performed by FPR criteria after injection of anesthetic, which is recorded by the child using its scoring image and the score is compared with the next session in the presence of another confusion.

3

Description
evaluation of pain by eye . movement and sound (SEM)
Timepoint
during injection of anesthesia
Method of measurement
The objective criterion used to assess the amount of pain is the SEM criterion, which assesses the condition of the child's eyes and movements according to the scoring table. The score is determined by the dental assistant during the injection of anesthesia with one of the needle beads in the session. They will then be measured and recorded with Digger's gauge and compared.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: injection of buccal maxillary infiltration anesthesia containing gauge needle 30. Anesthesia material is possible for you so that you can use articine as a c-kject needle by focal buccal infiltration with special features of ICT injection of genoss partners to 0.2 services. Intense collision
Category
Prevention

2

Description
Intervention group: injection of buccal maxillary infiltration anesthesia containing gauge needle 27. Anesthesia material is possible for you so that you can use articine as a c-kject needle by focal buccal infiltration with special features of ICT injection of genoss partners to 0.2 services. Intense collision
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Office of Doctor Hamid Sarlak
Full name of responsible person
Hamid Sarlak
Street address
5th floor, Corner of Mirahmad Doctors Building, Shahid Beheshti St.
City
Arak
Province
Markazi
Postal code
3817985467
Phone
+98 86 3222 3794
Email
dr.hamidsarlak@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afrooz Nakhostin
Street address
Alam Al-Huda St., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamid Sarlak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
5th floor, Corner of Mirahmad Doctors Building, Shahid Beheshti St.
City
arak
Province
Markazi
Postal code
3817985467
Phone
+98 86 3222 3794
Email
dr.hamidsarlak@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Sarlak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
5th floor, Corner of Mirahmad Doctors Building, Shahid Beheshti St.
City
arak
Province
Markazi
Postal code
3817985467
Phone
+98 86 3222 3794
Email
dr.hamidsarlak@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Najafi Haghi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Academic complex of the Payambar Azam, Basij squre, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3794 3222
Email
dr.mohammad_najafi@yahoo.com

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
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