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CTRI Number  CTRI/2025/07/090527 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing how different dental injection systems affect childrens pain, anxiety, and behavior during dental treatment 
Scientific Title of Study   Comparative assessment of behaviour, anxiety, pulse rate, and pain perception in children using different local anesthesia delivery systems: a randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Natasha Gambhir 
Designation  Professor and assistant dean 
Affiliation  Santosh dental college and hospital, santosh university 
Address  Department of pediatric and preventive dentistry, santosh dental college and hospital,Santosh University, 1, santosh nagar, sector 12, block H, pratap vihar

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  9871966965  
Fax    
Email  tash_aa@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonam Yadav 
Designation  Post graduate student 
Affiliation  Santosh dental college and hospital, santosh university 
Address  Department of pediatric and preventive dentistry, santosh dental college and hospital,Santosh University, 1, santosh nagar, sector 12, block H, pratap vihar

New Delhi
DELHI
110085
India 
Phone  09560135402  
Fax    
Email  ydvsonam112@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonam Yadav 
Designation  Post graduate student 
Affiliation  Santosh dental college and hospital, santosh university 
Address  Department of pediatric and preventive dentistry, santosh dental college and hospital,Santosh University, 1, santosh nagar, sector 12, block H, pratap vihar

New Delhi
DELHI
110085
India 
Phone  09560135402  
Fax    
Email  ydvsonam112@gmail.com  
 
Source of Monetary or Material Support  
Santosh dental college and hospital, ghaziabad 
 
Primary Sponsor  
Name  Dr Sonam Yadav 
Address  Department of pediatric and preventive dentistry, santosh dental college and hospital,Santosh University, 1, santosh nagar, sector 12, block H, pratap vihar 
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 Natasha Gambhir  Santosh dental college and hospital  Department of pediatric and preventive dentistry
Ghaziabad
UTTAR PRADESH 		 9871966965

tash_aa@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Santosh University Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Syringe  It is a traditional syringe-and-needle anesthesia delivery system commonly used in dentistry, typically requiring around 2 minutes to administer local anesthesia in a single visit 
Intervention  Starpen  It is an electronic local anesthesia delivery system specifically designed for use in dentistry, offering a painless and controlled injection experience. It typically administers anesthesia within approximately 1 minute in a single sitting 
Intervention  Vibraject  Vibraject is a battery-operated device attached to a conventional dental syringe that provides a vibratory effect during local anesthesia administration. It enhances patient comfort by reducing pain perception and typically delivers anesthesia within 1 minute in a single visit 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Children aged between 6 and 10 years were selected.
2.Only those receiving local anesthesia for the first time were included.
3.Patients requiring an Inferior Alveolar Nerve Block were considered.
4.Children exhibiting Frankl’s definitely positive or positive behavior were included.
 
 
ExclusionCriteria 
Details  1.Patients who had previously experienced local anesthesia administration.
2.Children with acute or chronic inflammation or an abscess at the injection site.
3.Patients with a history of traumatic or painful dental experiences.
4.Patients with underlying medical conditions or developmental anomalies.
5.Children who had taken any analgesic medication in the past 24 hours.
6.Patients with a known history of allergy to local anesthesia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To provide positive stress free dental experience and reduces pain perception,anxiety,and aids in behavioral management  Immediate 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   21/07/2025 
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="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ydvsonam112@gmail.com].

  6. For how long will this data be available start date provided 14-07-2025 and end date provided 30-09-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study will aim to compare behaviour, anxiety, pulse rate, and pain perception in children receiving inferior alveolar nerve blocks using StarPen, Vibraject, and conventional syringes. It is expected that StarPen will demonstrate the most favorable outcomes by significantly reducing pain, anxiety, and physiological stress, while also enhancing behavioral cooperation. The findings will support the future use of electronic delivery systems like StarPen as effective tools for improving patient experience in pediatric dentistry. 
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