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CTRI Number  CTRI/2024/03/063752 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Other 
Public Title of Study   To Compare and Evaluate Dental Anxiety and Fear In Children By Using Four different syringes for dental anesthesia  
Scientific Title of Study   Comparative Evaluation Of Dental Anxiety & Fear In Children By Using Star Pen-dental Anaesthesia Device, Vibrajet, Insulin Syringe And Camouflaged LA Syringe During Local Anaesthesia Administration  
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 Madhuri Bavaji Bhandare 
Designation  PG Student 
Affiliation  jawahar medical foundation annasaheb chudaman patil memorial dental college 
Address  Department of Pedodontics room no 5, 2nd floor,jawahar medical foundation annasaheb chudaman patil memorial dental college,Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9503156682  
Fax    
Email  bhandaremadhuri09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashant Arjun Bondarde 
Designation  Head Of Department, Professor 
Affiliation  jawahar medical foundation annasaheb chudaman patil memorial dental college 
Address  Department of Pedodontics room no 5, 2nd floor,jawahar medical foundation annasaheb chudaman patil memorial dental college,Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9370309008  
Fax    
Email  bondardeprashant@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhuri Bavaji Bhandare 
Designation  PG Student 
Affiliation  jawahar medical foundation annasaheb chudaman patil memorial dental college 
Address  Department of Pedodontics room no 5, 2nd floor,jawahar medical foundation annasaheb chudaman patil memorial dental college,Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9503156680  
Fax    
Email  bhandaremadhuri09@gmail.com  
 
Source of Monetary or Material Support  
Jawahar medical foundation annasaheb chudaman patil memorial dental college Dhule 
 
Primary Sponsor  
Name  Dr Madhuri Bhandare 
Address  Department of Pedodontics room no 5, 2nd floor,jawahar medical foundation annasaheb chudaman patil memorial dental college,Dhule 
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 Madhuri Bhandare  jawahar medical foundation annasaheb chudaman patil memorial dental college dhule   Room no 5 second floor Department of pedodontics jawahar medical foundation annasaheb chudaman patil memorial dental college dhule
Dhule
MAHARASHTRA 
9503156680

bhandaremadhuri09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
jawahar medical foundation annasaheb chudaman patil memorial dental college institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  camouflaged LA syringe  For local anaethesia administration during any dental treatment monitoring the anxiety level within 20 minutes 
Comparator Agent  insulin syringe   For local anaethesia administration during any dental treatment monitoring the anxiety level within 20 minutes 
Intervention  Starpen –dental anaesthesia device  For local anaethesia administration during any dental treatment monitoring the anxiety level within 20 minutes 
Comparator Agent  VibraJet –dental anaesthesia device  For local anaethesia administration during any dental treatment monitoring the anxiety level within 20 minutes 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children having their first dental visit
Healthy children with no systemic illness, allergies, etc.
Cooperative child.
Patient requiring local anesthetic injection for dental treatment either in maxillary or
mandibular arch.
Children with proper parental consent 
 
ExclusionCriteria 
Details  Children with emergency treatment needs, such as abscess, cellulitis and space
infection, and those who needed premedication for receiving dental treatment.
Medically compromised patient
Children with behavioural management problem
Children allergic to local anesthetic agents.
Children below 6 years of age 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate dental anxiety & fear in children by using star pen-dental anaesthesia device, vibrajet, insulin syringe and camouflaged l.a syringe during local anaesthesia administration
 
At the time before and after local anaesthesia
delivery prior treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To compare dental anxiety & fear in children by using star pen-dental anaesthesia device,
 
At the time before & after local anaesthesia
delivery prior treatment 
To compare dental anxiety & fear in children by using Vibrajey  At the time before & after local anaesthesia
delivery prior treatment 
To compare dental anxiety & fear in children by using Insulin syringe  At the time before & after local anaesthesia
delivery prior treatment 
To compare dental anxiety & fear in children by using camouflaged syringe  At the time before & after local anaesthesia delivery prior treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   12/03/2024 
Date of Study Completion (India) 11/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 11/06/2024 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

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

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhandaremadhuri09@gmail.com].

  6. For how long will this data be available start date provided 26-05-2024 and end date provided 27-05-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

INTRODUCTION:-

Dental fear and anxiety is one of the major challenges in pediatric dentistry . DFA is a common reason for avoiding dental treatment, which over time, may result in deteriorated oral health. Some children find it difficult to cope with the stimuli and behavioral demands associated with dental experience. This could be due to fear of the needle, bodily harm, or a general fear of the unknown. Successful treatment of pediatric patients, in terms of allaying their anxiety and discomfort during restorative and surgical procedures, is facilitated by  profound local anesthesia

In order to overcome this, many advanced injection techniques have been implemented. The most recent and advanced technique was using a Starpen-local anaesthetic device .and VibraJet-small  vibrating device to deliver dental anaesthesia.

METHODOLOGY-

Patient who satisfied the inclusion and exclusion criteria will be randomly divided into four groups consisting 10 patients each i.e. Group 1- Starpen –dental anaesthesia device , Group 2 – VibraJet –dental anaesthesia device, Group 3- Insulin Syringe and Group 4- Camouflaged L.A syringe ,Local anesthetic (LOX × 2% adrenaline) is delivered according to assigned group in the area adjacent to the tooth requiring invasive treatment procedure.

 Preoperative evaluation will be done before local anaesthesia admininistration by recording pulse rate and Venhams Picture Test which comprices 8 cards with 2 picture in each card one anxious  and one non anxious. The score ranges from  0 to 8 maximum score . Facial Image Scale - A subjective scale used to assess pain- A set of six cartoon faces will be shown to the child with varying facial expressions ranging from a very smiling face to a very sad face. A brief explanation will be given to the child about each face after which the child was instructed to choose the face that best described his/ her feelings before and after local anesthesia-Scores from 1 to 4.


 
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