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CTRI Number  CTRI/2022/01/039273 [Registered on: 10/01/2022] Trial Registered Prospectively
Last Modified On: 07/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “check the behaviour and anxiety in chlidren during local anesthesia administration by using conventional syringe and costum made economic sleev syringe a clinical trial 
Scientific Title of Study   “EVALUATION OF BEHAVIOR AND ANXIETY IN CHILDREN DURING LOCAL ANESTHESIA ADMINISTRATION USING CONVENTIONAL SYRINGE VS CUSTOM MADE ECONOMIC SLEEVE: A CLINICAL STUDY”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jalpa solanki 
Designation  postgreduate 
Affiliation  college of dental siences and hospital 
Address  KJ mehta TB hospital amargath, Bhavnagar, Gujarat
KJ mehta TB hospital amargath, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India 
Phone  6354509864  
Fax  00  
Email  jalpasolanki2413@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  dr vikram jhamb 
Designation  reader  
Affiliation  college of dental siences and hospital 
Address  KJ mehta TB hospital amargath, Bhavnagar, Gujarat
KJ mehta TB hospital amargath, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India 
Phone  6354509864  
Fax  00  
Email  dr.vikramjhamb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jalpa solanki 
Designation  postgreduate 
Affiliation  college of dental siences and hospital 
Address  KJ mehta TB hospital amargath, Bhavnagar, Gujarat
KJ mehta TB hospital amargath, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India 
Phone  6354509864  
Fax  00  
Email  jalpasolanki2413@gmail.com  
 
Source of Monetary or Material Support  
collage of dental science and Hospital, Amargadh, Bhavnagar, Gujarat.  
 
Primary Sponsor  
Name  jalpa solanki  
Address  kj mehta TB hospital department of pediatric and preventive dentistry Amargadh Bhavnagr 
Type of Sponsor  Private hospital/clinic 
 
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 
jalpa solanki  college of dental sciences hospital  KJ mehta TB hospital amargath Bhavnagar Gujarat
Bhavnagar
GUJARAT 		 6354509864

jalpasolanki2413@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 
Healthy Human Volunteers  VOLUNTEERS REQURED ANESTHESIA FOR THE DENTAL PROCEDURE 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COMPARITION BETWEEN CONVENSIONAL SYRINGE VS CUSTOM ECONOMIC SLEEV SYRINGE   2 ML CONVENTIONAL SYRINGE  
Intervention  CUSTOM MADE ECONOMIC SLEEVE SYRINGE   2 ml local anesthesia syringe COVERING WITH THE CUSTOM MADE ECONOMIC SLEEVE SYRINGE  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) Children aged between 6-11 years old who required local anesthesia during any dental procedure.
2) Those children are having positive and definitely positive Frankl behavior.
 
 
ExclusionCriteria 
Details  Medically compromise children.
Parents who refuse written consent.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to check the anxity and behavior  6 MONTHS  
 
Secondary Outcome  
Outcome  TimePoints 
coparition between behavior and anxity using conventinal syringe vs costim made sleev syringe  6months 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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   Phase 2 
Date of First Enrollment (India)   10/01/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [jalpasolanki2413@gmail.com].

  6. For how long will this data be available start date provided 01-03-2022 and end date provided 01-09-2022?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Before starting any treatment which required local anesthesia injection, 15% topical anesthetic spray (Lidocaine Topical Aerosol USP nummit) (Indian pharmaceutical combine association limited) administration at the injection site. And baseline pulse rate will be noted using a finger pulse oximeter. After that administration of local anesthesia in group 1: using conventional syringe and group 2: using custom made economical syringe during this procedure the co-investigator record   the pulse rate.

During the local anesthesia administration (2% Lignocaine hydrochloride & Adrenaline bitartrate) ((Indian pharmaceutical combine association limited)), co-investigator records video in Redmi 8A mobile with Resolution 1030p at 30fps. to grade the child’s behavior using the Faces, Legs, Arms, Crying, Consolability (FLACC) behavior pain scale 

Inclusion:

 

 

1)    Children aged between 6-11 year olds who required local anesthesia during any dental procedure.

2)    Those children are having positive and definitely positive frankl behavior.

 

 

 

 

 

 

                        

Exclusion:

 

1)    Medically compromise children.

2)    Parents who refuse written consent.
 
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