Comparison of anesthetic efficacy of 4% articaine and 2% lidocaine for maxillary primary molar buccal infiltration during routine dental treatment in 4-6years old children
In this study, the efficacy of articaine4% and lidocaine2% on anesthesia of first primary molars by infiltration injections will be compared in children4-6 years old. In this double blind randomized clinical trial, 74 children aged4-6 years attending pediatric departments of the Tabriz Dental School and they are candidates for the first primary molar pulpotomy, will be selected if they Provided the inclusion criteria. After giving the necessary explanations and obtaining consent from their parents, they will be divided randomly into two groups by Randlist software. In group 1, injections of buccal infiltration by two-thirds of articaine4% with epinephrine of1 /100,000 carpuls, and in the group2 , injections of buccal infiltration by two-thirds of the lidocaine2% with epinephrine of1/1, 80000 carpuls will be informed;It should be noted: Prior to injection, the anesthetic agents will be prepared in the coded syrings of the same type by a person who does not have an intervention in the study . This code will only be disclosed during data analysis; therefore, neither researcher nor patient will be informed of the grouping of patients. after5 minutes the treatment will be performed; and the anesthesia created in the two groups will be examined by observing the child's response during the dental work using the SEM scale (sound / eye / motor) . Children whose teeth are hyperemic or necrosis will be excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101036699N1
Registration date:2017-11-13, 1396/08/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-13, 1396/08/22
Registrant information
Name
Maryam Pourkazemi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 109 6853
Email address
pourkazemim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Tabriz University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2017-12-11, 1396/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthetic efficacy of 4% articaine and 2% lidocaine for maxillary primary molar buccal infiltration during routine dental treatment in 4-6years old children
Public title
Comparing of the efficay of Articaine and Lidocaine on Anesthesia of Maxillary first Molars in 4-6years old children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Children aged 4-6 years old; Children who are 3 or 4 in Frankel's terms of cooperation; Children with primary maxillary first molar teeth need pulpotomy treatment and confirmed radiographic symptoms require pulpal therapy; Children who have no inflammatory lesions (abscess, fistula) in their buccal mucosa; Children who do not desire spontaneous pain or nighttime pain in their teeth;
Exclusion criteria: Children who are 1 or 2 in Frankel's terms of cooperation; Children who need to surface restoration of the primary first molar; Children who require tooth extraction of the primary first molar; Children who have inflammatory lesions in their buccal mucosa; Tooth necrosis; Children who have spontaneous pain or nighttime pain in their teeth; Children who have hyperemic pulp after exposation of their teeth; Radiography of irreversible pulpitis symptoms such as internal resorbtion, external resorbtion, PDL dilatation, radiolucency in furca.
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Next to Imam Reza Hospital, end of Golgasht St., Azadi St., Tabriz
City
Tabriz
Postal code
5166614711
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.TBZMED.REC.1396.646
Health conditions studied
1
Description of health condition studied
Local anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anesthesia of the maxillary primary first molar
Timepoint
5 minutes after intervention and during work
Method of measurement
By observing the child's behavior with SEM(Sound-Eye-Motor) scale
Secondary outcomes
empty
Intervention groups
1
Description
In group 1, an infiltration with articaine 4% with epinephrine 1 /100,000 will be informed as following.The syringe is parallel to the longitudinal axis of the tooth at the depth of the buccal mucosa groove and Up to reaching the tip of the needle into the apex of the buccal roots of the first molar will be drowned, Then in about 30 seconds, about two-thirds of the carpul (1 ml) will be injected. After 5 minutes the treatment will be done. It should be noted that injections and all operations will be performed by a same pediatric dentist
Category
Treatment - Drugs
2
Description
In group2, an infiltration of lidocaine 2% with epinephrine of 1/1: 80000 will be informed as following. The syringe is parallel to the longitudinal axis of the tooth at the depth of the buccal mucosa groove and Up to reaching the tip of the needle into the apex of the buccal roots of the first molar will be drowned, Then in about 30 seconds, about two-thirds of the carpul (1 ml) will be injected. After 5 minutes the treatment will be done. It should be noted that injections and all operations will be performed by a same pediatric dentist
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatrics Department of the Tabriz Dentistry Faculty