Objectives : Maxillary Buccal Infiltration and Inferior Alveolar Nerve Block(IANB) are the most common techniques to achieve anesthesia for routine dental procedures of maxillary and mandidular teeth ,respectively . Prilocaine is one of the anesthetic solution which specially practical in some systemic diseases.There are two commercial types of Prilocaine naming Citanest and Dentanest . The aim of this study was to compare the anesthetic efficancy of these two solutions regarding the onset and duration .
Design: This study designed randomized cross-over clinical trial.
Setting and Conduct : Maxillary Buccal Infiltration and IANB were applied by one trained practitioner and the onset and duration of pulpal and soft tissue anesthesia were measured using EPT and Pin Prick ,respectively every 2minutes for a period of 60 minutes . Subjects with no sign of lip anesthesia 20min after receiving IANB were excluded from the study.The obtained data were analyzed using T-test and Wilcoxon test.
Participants including major eligibility criteria : In this study participated 20 healthy subjects which had maxillary and mandibular molars with no caries , large restorations , crowns and periodontal diseases .They written informed consent was obtained from each subject.
Intervention : Age , Needle gauge , tooth type , periodontal disease , Injection duration .
Measures variables : Onest of pulpal anesthesia in maxillary buccal infiltration , pulpal duration of maxillary buccal infiltration , onset of pulp in IANB , pulpal duration of IANB .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102319207N2
Registration date:2016-01-25, 1394/11/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Bahareh Dadresanfar
Name of organization / entity
Islamic Azad university of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 912 575 4371
Email address
b_dadresanfar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison anesthetic onset and duration of Citanest and Dentanest in maxillary and mandibullary molars with normal pulps.
Public title
Comparison citanest and dentanest
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria : Subjects between 18 to 65 yrs ; had not any systemic disease ; they had not used any medication ; had not sensitivity to anesthesia solution ; had not pathology in injection area ; had fist or second maxillary and mandibulary molars
Exclusion criteria : Caries and crown and periodontal disease in studied molars ; pragnancy ; systemic disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
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 committe of Islamic Azad University of Dentistry tehran branch
Street address
10th Neyestan , Pasdaran
City
Tehran
Postal code
Approval date
2014-02-25, 1392/12/06
Ethics committee reference number
د/320/پ
Health conditions studied
1
Description of health condition studied
onset and duration of pulpal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Onset of Pulp and Soft tissue anesthesia
Timepoint
Per 2-minute post injection
Method of measurement
Electric Pulp Tester ( EPT) , Pin Prick
Secondary outcomes
1
Description
Duration of Pulp and Soft tissue anesthesia
Timepoint
Every 2- minute post injection
Method of measurement
Electric Pulp Tester , Pin prick
Intervention groups
1
Description
Intervention:1.8ml ( one catrige ) Dentanest( Perilocaine 3% with 0/03 flypersine) once during 30 to 60 seconds in Maxillary buccal infiltratin and Inferior Alveolar Nerve Block.
Category
N/A
2
Description
Control group : 1.8 ml (one cartrige ) Citanest (Perilicaine 3 % with 0/03 flypersin ) once during 30 to 60 seconds in Maxillary Buccal Infiltration and Inferior Alveolar Nerve Block .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University,Dental Branch of Tehran ,Endodontics department
Full name of responsible person
Dr. Pooneh Mohebbi
Street address
10th Neyestan , Pasdaran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanceller for research,Azad university of dentistry
Full name of responsible person
Dr.Pooneh Mohebbi
Street address
Endodantics Department,10th Neyestan,Pasdaran ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceller for research,Azad university of dentistry