Comparative evaluation of the efficacy of two anesthetic gels Lidocaine 20% and Benzocaine 20% in reducing pain during posterior maxillary infiltration in children aged 7-12 years
To evaluate the effectiveness of lidocaine and benzocaine gels in reducing pain during posterior maxillary infiltration injection in children aged 7 to 12 years
Design
Controlled clinical trial, double blinded, randomized, phase 3 on 24 patients. Children are allocated into two groups: Group A 20% lidocaine gel, Group B 20% benzocaine gel. Letters A and B are written on two papers and both placed in an envelope. A pediatric dental specialist, who is blinded to the group assignments, choose one of the letters A and B from the envelope.
Settings and conduct
In this study, patients presenting to the pediatric department of the Faculty of Dentistry at Azad University in Tehran are selected through continuous sampling. The study population comprises children aged 7 to 12 years. The child, the pain recorder, and the pediatric dentist administering the injection are all blinded to the type of anesthetic gel, ensuring that none are aware of which gel is being used. The researcher has prepared both gels in separate, unlabeled tubes, ensuring that only the researcher is aware of the specific gel contained in each tube.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children in need of pulp therapy, restorative treatments, and tooth extractions; Children classified as ASA1 and ASA2; Positive and strongly positive Frankel behavioral rating; Absence of abscess and fistula; No prior pain in the area of study.
Exclusion criteria: Allergy to local anesthetics; Use of neuroblocking medications; Non-cooperative child
Intervention groups
First intervention group: using lidocaine gel in reducing pain during infiltration injection.
Second intervention group: using benzocaine gel in reducing pain during infiltration injection.
Main outcome variables
Child's Pain Level in Wong-Baker scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240616062152N1
Registration date:2024-08-07, 1403/05/17
Registration timing:prospective
Last update:2024-08-07, 1403/05/17
Update count:0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Kimia Aghdasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2611 5971
Email address
kimia.aghdasi4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the efficacy of two anesthetic gels Lidocaine 20% and Benzocaine 20% in reducing pain during posterior maxillary infiltration in children aged 7-12 years
Public title
The effect of anesthetic gel (lidocaine and benzocaine) in reducing injection pain in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children in need of pulp therapy, restorative treatments, and tooth extractions
Children with ASA grade 1 and 2
Frankel’s classification grade positive and strongly positive
Absence of abscess and fistula
No prior pain in the area of study
Exclusion criteria:
Allergy to local anesthetics
Use of neuroblocking medications
Non-cooperative child
Age
From 7 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Children are randomly divided into two groups: Group A will receive 20% lidocaine gel, and Group B will receive 20% benzocaine gel. The treatment allocation is written on two paper slips as A and B letters and both placed in an envelope. A pediatric dental specialist, who is blinded to the group assignments, choose one of the letters A and B from the envelope to determine which gel will be used for each patient initially. The dental procedures will be carried out on the right or left side based on the child's treatment priority.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher prepared both gels in two separate tubes without a gel name label so only she knows the type of gel in each tube.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical sciences
Street address
No. 9 , Neyestan 9 street, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2024-05-19, 1403/02/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1403.048
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain level in Wong - Baker scale
Timepoint
Immediately after the infiltration injection
Method of measurement
Wong Baker Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Receiving 20% lidocaine gel with strawberry flavor, manufactured by the Prodofix brand in Iran. Initially, the target mucosa will completely make dried, then 2 millimeters of gel will be placed on the applicator and pressed onto the area for 30 seconds.
Category
Treatment - Drugs
2
Description
Second intervention group: Receiving 20% benzocaine gel with strawberry flavor, manufactured by the Master-Dent brand in the USA. Initially, the target mucosa will be make completely dried, then 2 millimeters of gel will be placed on the applicator and pressed onto the area for 30 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Islamic Azad University
Full name of responsible person
Afshin Haraji
Street address
No. 9, Neyestan 9 street, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Afshin_haraji@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No.9, Neyestan 9 street, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Tehran University of Medical Sciences
Full name of responsible person
Sara Zahedi Rad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Unit No.2291, Tehran tower, South Sheikh-bahaei street
City
Tehran
Province
Tehran
Postal code
۱۴۳۷۷۷۳۷۸۷
Phone
+98 21 9666 1044
Email
szahedirad@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Zahedi Rad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.2291, Tehran tower, South Sheikh bahaei street
City
Tehran
Province
Tehran
Postal code
1437773787
Phone
+98 21 9666 1044
Email
szahedirad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kimia Aghdasi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.9 , Neyestan 9 street, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Kimia.aghdasi4@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Pain level, age, Sex
When the data will become available and for how long
The beginning of the access period starting from 1403
To whom data/document is available
University and non-university institutions
Under which criteria data/document could be used
To assist in conducting supplementary research
From where data/document is obtainable
Kimia.aghdasi4@gmail.com
Kimia Aghdasi
What processes are involved for a request to access data/document