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CTRI Number  CTRI/2018/01/011639 [Registered on: 31/01/2018] Trial Registered Retrospectively
Last Modified On: 21/08/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   omparative evaluation of 4% articaine with 2% lignocaine for extractions of deciduous maxillary teeth. 
Scientific Title of Study   Comparative evaluation of anesthetic efficacy of buccal infiltration anesthesia using 4% articaine with buccal and palatal infiltration using 2% lignocaine for extractions of deciduous maxillary teeth. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayashree Jankar 
Designation  Post Graduate Student 
Affiliation  Department of Pedodontics and Preventive Dentistry, MGVs KBH Dental College and Hospital, Nashik 
Address  Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik

Nashik
MAHARASHTRA
422003
India 
Phone    
Fax    
Email  jayashreejankar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhushan Pustake 
Designation  Professor and Guide 
Affiliation  Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik 
Address  Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik

Nashik
MAHARASHTRA
422003
India 
Phone    
Fax    
Email  bhushanpustake@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jayashree Jankar 
Designation  Post Graduate Student 
Affiliation  Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik 
Address  Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik

Nashik
MAHARASHTRA
422003
India 
Phone    
Fax    
Email  jayashreejankar@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Jayashree Jankar 
Address  D-703, Sumer Castle, Castle Mill Naka, LBS Road, Thane-West 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayashree Jankar  MGVs KBH Dental College and Hospital, Nashik.  Room no-605,Department of Pedodontics and Preventive Dentistry.
Nashik
MAHARASHTRA 
9820656654

jayashreejankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGVs KBH Dental College and Hospital, Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  indicated for bilateral maxillary deciduous teeth extraction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% Lignocaine Hydrochloride  2% Lignocaine Hydrochloride with 1:80,000 Epinephrine 
Intervention  4% Articaine Hydrochloride  4% Articaine Hydrochloride with 1:100,000 Epinephrine 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children in the age group of 5-10 years requiring administration of local anesthetic agent for bilateral extractions of maxillary deciduous teeth, Children falling in the Frankel behaviour rating scale of positive and definitely positive, No history of intra-oral injections, Only children whose parental consent is obtained before procedure.

 
 
ExclusionCriteria 
Details  Allergy to sulfites or amide type of local anesthetics, Severe systemic disease contraindicating tooth extraction, Evidence of soft tissue infection near the proposed injection site, Inability to give informed consent, Taking any medications that might alter pain perception or anesthetic assessment.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of anesthesia  At the day of intervention (0 day) 
 
Secondary Outcome  
Outcome  TimePoints 
Any adverse effects  At the day of intervention (0 day) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/06/2016 
Date of Study Completion (India) 14/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Pain control in dentistry is an important part in reducing the fear and anxiety associated with dental procedures especially in children. Pain on palatal injection is a very commonly experienced symptom in dentistry and as such is a major concern to dentist. A number of techniques may be used to reduce the discomfort of intra-oral injections, the application of topical anaesthetic being a well-known and frequently used option. However, it is effective only on surface tissues (2–3 mm) and tissues deep to the area of application are poorly anesthetized. Surface anaesthesia does allow for atraumatic needle penetration, but because of the density of the palatal soft tissues and their firm adherence to the underlying bone, palatal injection is still painful. Local anaesthetics form the backbone of pain control in dentistry and there has been substantial research for safe and effective local anaesthetic agent. 2% lignocaine is the “gold standard” to which all new local anaesthetics are compared and considered most efficacious anaesthetic agent for use in pediatric and adult patients. Articaine is unique amide local anaesthetics that consist of ester group and thiophene ring which makes it more potent and more lipid soluble and accounts for faster diffusion properties within tissues and bone. Due to this property of diffusion, profound anaesthesia can be achieved on palatal side with buccal infiltration. It has been claimed that articaine is able to diffuse through soft and hard tissues more reliably than other local anaesthetics and that maxillary buccal infiltration of articaine provides palatal soft tissue anaesthesia, obviating the need for a palatal injection which in many hands, is traumatic. Hence, the present study was conducted to evaluate clinically the anesthetic efficacy of only buccal infiltration anesthesia using 4% articaine with buccal plus palatal infiltration using 2% lignocaine for extractions of deciduous maxillary teeth.

 
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