the aim of this study is to evaluate and compare the anesthetic efficacy of a single buccal infiltration of 4% articaine with routine infra dental block using 2% lidocaine during the injection and extraction of primary mandibular molars
Design
A prospective, randomized,blinded, controlled clinical trial with a parallel group design of 100 patients was conducted.
Settings and conduct
one group(treatment group)receive mandibular infiltration with articaine 4% with intrapapillary infiltration for lingual analgesia; the other group(control group) receive an inferior dental block with 2% lidocaine supplemented with long buccal infiltration.The anesthetic solution in both groups is delivered using a dental syringe and a 15 mm long 27-gauge needle and with standardized rate of injection (to ~1 ml/min) in Shahid Beheshti dental school and pediatric dentists office in Tehran.The pain assessment is carried out using Wong- Baker Faces Pain Rating Scale (W-BFSR) and Frankl Behaviour Rating Scale (FBRS).
Participants/Inclusion and exclusion criteria
Inclusion Criteria:1) Having a mandibular primary molar tooth
that required extraction 2)Medically fit (ASA I, II) 3) Mentally capable of communication 4)A good understanding of persian 5)The
tooth should have had no history of infection (abscess) or swelling or pain
Exclusion Criteria:1)Medical)History of significant behaviour management problems3)Evidence of infection or abscess near the proposed injection site
Intervention groups
the pain during of injection and treatment is being assessed in case group which received mandibular infiltration with 4% articaine, with intrapapillary infiltration and control group which received an infra dental block with 2% lidocaine supplemented by long buccal infiltration.
Main outcome variables
The pain during treatment/The pain during injection/ Method of injection/Gender/ Age
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220129053868N1
Registration date:2023-03-01, 1401/12/10
Registration timing:registered_while_recruiting
Last update:2023-03-01, 1401/12/10
Update count:0
Registration date
2023-03-01, 1401/12/10
Registrant information
Name
Bornadokht Bazghandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 0098
Email address
b.bornadokht@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-27, 1401/12/08
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anesthetic Efficacy of Buccal Infiltration of 4% Articaine compared to Block Injection with 2% Lidocaine for Extraction of Mandibular Primary Molars
Public title
Anesthetic Efficacy of Infiltration of Articaine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Mandibular Primary Molars that required extraction
medically fit(ASA I,II)
Mentally capable of communication
A good understanding of Persian
Having no history of pain or infection (abscess) or swelling
Exclusion criteria:
Medically and mentally compromised children
History of significant behaviour management problems
Evidence of infection or abscess near the proposed injection site
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block Permutation
Blinding (investigator's opinion)
Double blinded
Blinding description
informing parents not children
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No. 34, South Shiraz Ave., Alikhani Blvd.
City
Tehran
Province
Tehran
Postal code
1436937554
Approval date
2021-12-27, 1400/10/06
Ethics committee reference number
IR.SBMU.DRC.REC.1400.107
Health conditions studied
1
Description of health condition studied
Anesthetic efficacy for extraction of mandibular primary molars
Control group: Block Injection with 2% Lidocaine epinephrine 1/100000(Persocaine-E, Darou Pakhsh)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Shahid Beheshti
Full name of responsible person
Sanaz Kamareh
Street address
Daneshjou Blvd.
City
Tehran
Province
Tehran
Postal code
1436937554
Phone
+98 21 8860 0098
Email
b.bornadokht@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
School of Dentistry,Shahid Beheshti University of Medical science,Daneshjoo Blvd,Daneshgah(Shahriari) Square,Evin,Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2203 2387
Email
Zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bornadokht Bazghandi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 34, Aghaalikhani Blvd, South Shiraz Ave, Azadegan
City
Tehran
Province
Tehran
Postal code
1436937554
Phone
+98 21 8860 0098
Fax
Email
b.bornadokht@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sanaz Kamareh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric Dentist
Street address
School of Dentistry,Shahid Beheshti University of Medical science,Daneshjoo Blvd,Daneshgah(Shahriari) Square,Evin,Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2203 2387
Email
Sanaz.Kamareh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Bornadokht Bazghandi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 34, Aghaalikhani Blvd, South Shiraz Ave, Azadegan
City
Tehran
Province
Tehran
Postal code
1436937554
Phone
+98 21 8860 0098
Fax
Email
b.bornadokht@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The recorded data can be shared based on the studied indicators after identifying the sample individuals,these data include the numbers and scores from the Wong- Baker Faces Pain Rating Scale, Frankl Behaviour Rating Scale,Visual Analogue Scale , as well as the results of statistical analysis of these data.
When the data will become available and for how long
e.g. strating 6 months after publication
To whom data/document is available
researchers working in academic and scientific institutes can apply for access to the data
Under which criteria data/document could be used
performing statistical analyzes to compare data with other studies in this field is one of the conditions for access to data.so the analysis must be appropriate to the type of data recieved from the applicant.
From where data/document is obtainable
applications can obtain access to the data by submitting a request to the following emails in due time.moderator: bornadokht bazghandi
What processes are involved for a request to access data/document
After submitting the request by email and also sending the request to whatsapp of the specified person,the applicant will be able to access the information within one week after submitting he request, if she has the requisite conditions.