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CTRI Number  CTRI/2023/06/054445 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 22/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two dental injection techniques in terms of pain perception in children during dental treatment 
Scientific Title of Study   Comparison of pain perception during administration of local anesthesia with jet injector and conventional injection technique using Wong- Baker scale in 6-12 years old children – a randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manali Khole 
Designation  Post graduate student 
Affiliation  Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur 
Address  Second floor,202, Department of pediatric and preventive dentistry, Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur, Maharashtra 441110, India.

Nagpur
MAHARASHTRA
441110
India 
Phone  8149332558  
Fax    
Email  manalikhole1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pankaj Chavhan 
Designation  Reader and pg guide 
Affiliation  Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur 
Address  Second floor,202, Department of pediatric and preventive dentistry, Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur, Maharashtra 441110, India.

Nagpur
MAHARASHTRA
441110
India 
Phone  9923106330  
Fax    
Email  drpankajchavhan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manali Khole 
Designation  Post graduate student 
Affiliation  Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur 
Address  Second floor,202, Department of pediatric and preventive dentistry, Swargiya dadasaheb smruti kalmegh dental college and hospital, Hingna, Nagpur, Maharashtra 441110, India.

Nagpur
MAHARASHTRA
441110
India 
Phone  8149332558  
Fax    
Email  manalikhole1@gmail.com  
 
Source of Monetary or Material Support  
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur, Maharashtra 
 
Primary Sponsor  
Name  Dr Manali Khole 
Address  Second floor, 202, Department of pediatric and preventive dentistry,Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur, Maharashtra 
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 Manali Khole  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital  Second floor, 202, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital , Hingna, Nagpur, Maharashtra, 441110, India
Nagpur
MAHARASHTRA 
8149332558

manalikhole1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional injection method  The injection site will be cleaned and prepared with sterile dry gauze and a small quantity of topical anesthetic will be kept in place for at least 1 min.0.6ml will be used for buccal infiltration and for palatal 0.2ml will be used.Palatal infiltration will be given first. Then Pain perception will be recorded using Wong Baker Scale. After each infiltration Wong- Baker reading will be recorded and mean will be calculated for buccal and palatal infiltration.The Pulse Rate will be calculated with pulse oximeter before administration of Local anesthesia (pre induction) and also after administration of Local anesthesia (post induction). The injection will be used once for palatal infiltration on one side for each patient. 
Intervention  Jet Injector System  The injection site will be cleaned and prepared with sterile dry gauze and a small quantity of topical anesthetic will be kept in place for at least 1 min. 0.5 cc will be used for buccal infiltration and for palatal 0.2cc will be used. Palatal infiltration will be given first. Then Pain perception will be recorded using Wong Baker Scale. After each infiltration Wong- Baker reading will be recorded and mean will be calculated for buccal and palatal infiltration.The Pulse Rate will be calculated with pulse oximeter before administration of Local anesthesia (pre induction) and also after administration of Local anesthesia (post induction).  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Aged between 6 -12 years requiring bilateral maxillary local anesthesia.
Having sufficient mouth opening.
Operation only on primary teeth decayed teeth that require anesthesia.
No history of previous administration of anesthesia.
ASA I category will be selected.
 
 
ExclusionCriteria 
Details  Medically compromised patient.
Dental phobia.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is to assess Pain perception using Wong- Baker scale.  Specific time at which the outcome will be assessed/estimated i.e. at baseline single intervention 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is to measure pulse rate.  Specific time at which the outcome will be assessed/estimated i.e. before & after intervention. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Needle-related pain (NRP)/ Blenophobia occurs most frequently during anesthesia in dentistry. In children, the pain from NRPs can produce an emotional and negative cognitive response towards the procedure. Pain has long been associated with dentistry and has an unusual relation and is the main reason that leads the patient to seek dental treatment. In addition, dental fear and anxiety are the main causes that may lead patients to bypass dental appointments. Fear-related behaviors have long been recognized as the most serious aspect of patient management and can be an impediment to dental care. For invasive procedures, pain control is achieved typically by means of injection of local anesthesia. Although this method is highly effective, it is also the dental procedure that is most often associated with anxiety and negative responses. For some patients, the injection itself is painful, and thus the procedure that is designed to reduce pain may itself result in fear and procrastination. In addition, patients often experience more fear at the sight of a needle during the administration of local anesthetic than from the treatment itself. Therefore, dentists have attempted to minimize the intensity of NRP associated with any dental problem. The objective fear of the child during administration of local anesthesia ranges from sight of the needle to the pain that might be associated with needle injection, which increases the anxiety of the patient resulting in fear of receiving local anesthesia in the future. Thus, there is a need for attempting use of  several methods to minimize pain during administering local anesthesia. Jet-injector are needle-free systems that work with the principle of applying anesthetic solution with pressure to penetrate the tissues with spring-loaded devices, in a manner reinforced with pressurized air or gas. To the best of our knowledge, limited literature is available on the pain perception of the jet injectors on pediatric population. In this study, we aimed to compare the pain perception of jet injector method and conventional injection method in a pediatric population of age 6-12 years.

Primary Objectives: To compare the effect of the jet injection and conventional injection method on pain perception in children 6-12 years of age using Wong- Baker scale.

Methodology: Children coming in the department of pedodontics and preventive dentistry will be included in study and requiring administration of local anesthesia  on both sides of maxilla will be included in study for various procedures. Based on inclusion criteria, 50 children of age group 6- 12 years will be selected for study. Both the genders will have equal opportunity to participate in the study. Each child will be assigned for both the jet injector and conventional injection technique. Method to be administered first will be decided alternately and the side determination will be done by flip the coin technique.

 
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