Comparison of the Effectiveness of Benzocaine gel and Lidocaine- Prilocaine cream on Pain and Anxiety Reduction due to Dental Infiltration Anesthesia in Primary Upper Teeth
Comparison of the effectiveness of Benzocaine gel and Lidocaine- Prilocaine cream on pain and anxiety reduction due to dental infiltration injection in upper primary posterior teeth
Design
A double- blinded third phase clinical trial with 2 experimental groups and cross over group design of 21 patients
Settings and conduct
After specimens selection, children are randomly divided into two groups A (n = 11) and B (n = 10). In group A, in the first session of treatment after drying the mucosa, 0.5 g of lidocaine-5% surface anesthetic will be applied for 3 minutes and in the second session 0.5 g of benzocaine surface anesthesia gel will be applied for 30 seconds. While the group B, will go to a vise versa process. The child is not aware of the type of topical anesthesia agents. After application of topical anesthesia, infiltration injection is performed. In both sessions, before using topical anesthesia, during the injection, and finally after the injection, the child's heart rate is measured by the pulse oximeter and the reactions during the injection is recorded by the CPS Scale.Wong Baker Facial Pain Scale(wbfps) is used for recording the pain due to injection. The outcome adjudicator is not aware of the type of experimental agent .
Participants/Inclusion and exclusion criteria
4 to 9 years old children
Children without systemic problems
Children without history of previous dental treatment Children requiring two symmetric posterior upper primary molars infiltration injection
Intervention groups
In group A, in the first session of treatment, Lidocaine-Prilocaine 5% (EMLA) will be used for 3 minutes and in the second session, Benzocaine will be used for 30 seconds, while for the group B, Benzocaine gel will be used on oral mucosa in the first visit and in the second one we will use lidocaine-prilocaine cream.
Main outcome variables
Type of topical anesthesia; Heart rate; CPS scale; WBFPS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210908052409N1
Registration date:2022-01-24, 1400/11/04
Registration timing:retrospective
Last update:2022-01-24, 1400/11/04
Update count:0
Registration date
2022-01-24, 1400/11/04
Registrant information
Name
Bardia Hasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2269 3417
Email address
bardia.hasani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-25, 1399/07/04
Expected recruitment end date
2021-02-22, 1399/12/04
Actual recruitment start date
2020-09-25, 1399/07/04
Actual recruitment end date
2021-02-23, 1399/12/05
Trial completion date
2021-02-23, 1399/12/05
Scientific title
Comparison of the Effectiveness of Benzocaine gel and Lidocaine- Prilocaine cream on Pain and Anxiety Reduction due to Dental Infiltration Anesthesia in Primary Upper Teeth
Public title
Comparison of the Effectiveness of Benzocaine gel and Lidocaine- Prilocaine cream on Pain and Anxiety Reduction due to Dental Injection in Primary Teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
4-9 years old children
Children without systemic diseases
Children without history of previous dental treatment Requiring two symmetric posterior primary upper teeth infiltration injection
Exclusion criteria:
Age
From 4 years old to 9 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
21
More than 1 sample in each individual
Number of samples in each individual:
2
Upper buccal gingiva in both side of each patient
Actual sample size reached:
21
More than 1 sample in each individual
Actual sample size in each individual:
2
Upper buccal gingiva in both side of esch patient
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant is not aware of the type of topical anesthesia before dental injection. Also , a dental assistant as an outcome adjudicator doesn't know about the type of experimental agent .
Placebo
Not used
Assignment
Crossover
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
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.SBMU.DRC.REC.1399.043
Health conditions studied
1
Description of health condition studied
Pain and anxiety due to anesthesia infiltration injection in pediatric dentistry
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The perceived pain degree using Wong Baker Faces Pain scale(wbfps), the assessed pain and anxiety using children’s Hospital of Eastern Ontario Pain Scale (CPS), heart rate ratio using pulse oximeter
Timepoint
Recording the degree of perceived pain after injection using Wong Baker Facial Pain Scale(wbfps) . Pain and anxiety assessment using CPS Scale during injection. Assessment of heart rate before, during and after injection using pulse oximeter device .
Method of measurement
Recording the degree of perceived pain after injection using Wong Baker Facial Pain Scale . Pain and anxiety assessment using CPS Scale during injection. Assessment of heart rate before, during and after injection using pulse oximeter device .
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In this group , in the first session of treatment after drying the mucosa, 0.5 g of lidocaine-5% surface anesthetic will be applied for 3 minutes and in the second session 0.5 g of benzocaine surface anesthesia gel will be applied for 30 seconds. The child has upright position with headsupport and he/she is not aware of the type of topical anesthesia agents. After application of topical anesthesia, infiltration injection is performed. In both sessions, before using topical anesthesia, during the injection, and finally after the injection, the child's heart rate is measured by the pulse oximeter and the reactions during the injection is recorded by the CPS Scale.Wong Baker Facial Pain Scale is used for recording the pain due to injection. The outcome adjudicator is not aware of the type of experimental agent .
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: In this group , in the first session of treatment after drying the mucosa, 0.5 g of benzocaine surface anesthesia gel will be applied for 30 seconds and in the second session 0.5 g of lidocaine-5% surface anesthetic will be applied for 3 minutes. The child has upright position with headsupport and he/she is not aware of the type of topical anesthesia agents. After application of topical anesthesia, infiltration injection is performed. Same as the previos group, in both sessions, before using topical anesthesia, during the injection, and finally after the injection, the child's heart rate is measured by the pulse oximeter and the reactions during the injection is recorded by the CPS Scale.Wong Baker Facial Pain Scale is used for recording the pain due to injection. The outcome adjudicator is not aware of the type of experimental agent .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric ward of school of dentistry, Shahid Beheshti Univercity of Medical Science
Full name of responsible person
Kiana Poorzandpoush
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Email
Dentalschoolinfo@sbmu.ac.ir
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 Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
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
70
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
Kiana Poorzandpoush
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 4428
Email
Kianapoorzand@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali asghar soleimani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2211 2187
Email
drsoleymaniali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kiana Poorzandpoush
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Daneshgah (Shahriari) Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
198396411
Phone
+98 21 2242 4428
Email
Kianapoorzand@sbmu.ac.ir
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 reported from the Wong Baker FACES Pain Rating Scale, Houpt Scale, and numbers recorded from the finger pulse oximeter at specified times, as well as the results of statistical analysis of these data.
When the data will become available and for how long
e.g., starting 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 received from the applicant.
From where data/document is obtainable
Applicants can obtain access to the data by submitting a request to the following emails in due time. Moderator: Bardia Hasani Email address: bardia.hasani@gmail.com WhatsApp number: +989012879632
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 the request, if she has the requisite conditions.