Comparison of effectiveness of articaine and lidocaine on depth of anaesthesia in maxillary primary molars teeth in children 6 to 9 years old
Design
Phase III clinical trial with control group and parallel design is double blinded and block randomized.
Concealed controlled trial includes 30 patients enrolled between December 2019 and March 2020.
Settings and conduct
The study will be carried out in dentistry faculty, Shahid Sadoughi University of Medical Sciences.
Data collector, patients and statistics analyst will not be aware of type of intervention.
Participants/Inclusion and exclusion criteria
Children 6 to 9 years old who require bilateral extraction of primary maxillary molars and are grade 3 or 4 of frankl behavior rating scale.
The tooth is unrestorable and at least one third of the root length has remained.
Children have no systemic disease, drug allergy or learning disability, and they have ability of communication in persian language.
Intervention groups
The study has two groups. Respectively, articaine in the intervention group and lidocaine in the control group are used as anaesthesia drug in order to extract tooth.
Main outcome variables
Pain value using Wong Baker Facial Pain Scale and Face Leg Activity Cry Consolability.
Blood pressure and Pulse rate before and after anaesthesia injection and after tooth extraction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191002044953N1
Registration date:2019-12-26, 1398/10/05
Registration timing:registered_while_recruiting
Last update:2019-12-26, 1398/10/05
Update count:0
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Nahid Maghsoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3781 1631
Email address
nahidmaghsoodi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Articaine and Lidocaine on Depth of Anaesthesia in Maxillary Primary Molars Teeth
Public title
Maxillary Primary Molars Anaesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children who require bilateral extraction of primary maxillary molars
Children with grade 3 or 4 of frankl behavior rating scale
Unrestorable primary maxillary molars
primary maxillary molars with at least one third of the root length
Children without systemic disease or drug allergy
Children with ability of communication in persian language
Children without learning disability
Exclusion criteria:
Uncooperative children
Teeth with acute abscess
Use of analgesics before treatment
Failure in complete anaesthesia after injection
Age
From 6 years old to 9 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
According to bilateral extraction of the teeth, every patient has two samples.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method was blocked.
Randomization unit was individual.
Randomization tool was sealed envelops.
For allocation concealment, two sealed envelops were used for every patient in the first appointment; one determined extraction side and another was for drug type.
Blinding (investigator's opinion)
Double blinded
Blinding description
The principle investigator who is aware of type of intervention would inject and extract tooth. The blinded dentist would collect the data.
Considering blinding of data collector and the patient in every appointment, this study is double blinded.
Also, the statistics analyst is not aware of type of intervention for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Effectiveness of articaine in comparison to lidocaine during maxillary primary molars extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of self-reported pain by children during maxillary primary molars extraction based on Wong Baker Facial Pain Scale after anaesthesia with lidocaine or articaine
Timepoint
After tooth exrtraction
Method of measurement
Wong Baker Facial Pain Scale
2
Description
Calculated score of child pain by investigator during maxillary primary molars extraction based on Face Leg Activity Cry Consolability Scale after anaesthesia with lidocaine or articaine
Timepoint
During tooth exrtraction
Method of measurement
Face Leg Activity Cry Consolability Scale
Secondary outcomes
1
Description
Blood pressure changes before and after tooth extraction
Timepoint
before and after tooth extraction
Method of measurement
Blood prassure monitor
2
Description
Pulse rate changes before and after tooth extraction
Timepoint
Before and after tooth extraction
Method of measurement
Pulse Oximeter
Intervention groups
1
Description
Intervention group: Injection of 1.8 ml of 4% articaine with 1:100000 epinephrine in buccal infiltration
Category
Treatment - Drugs
2
Description
Control group: Injection of 1.8 ml of 2% lidocaine with 1:100000 epinephrine in buccal and palatal infiltration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Shahid Sadoughi University of Medical Sciences
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Undetectable information such as age, sex, type of tooth under extraction (first or second molar), amount of root length remaining to be extracted, and previous dental treatments history will be published.
Study outcomes will also be published, including changes in blood pressure, pulse rate, Wong-Baker Facial Pain Scale and Face Leg Activity Cry Consolability Scale.
When the data will become available and for how long
Starting 9 months after publication.
To whom data/document is available
The data are only available for people working in academic institutions.
Under which criteria data/document could be used
Use of this data is permitted for systematic review and meta-analysis.
Similar clinical trials can also use the data to criticize the present study and its results in their Discussion.
From where data/document is obtainable
1. Send an email to nahidmaghsoodi@yahoo.com
2. Send an email to zbahrololoom@yahoo.com
3. Telephone Call with Dr. Zahra Bahrololoomi, No. 983536214257.
What processes are involved for a request to access data/document
After the request via one of the three methods listed above, if the request matches the sharing information mentioned before, this information will be available to the applicant within one month.