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CTRI Number  CTRI/2025/04/084095 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study Comparing Pain and Anxiety in Children During Local Anesthesia: Which Injection Method Works Best?  
Scientific Title of Study   Comparative evaluation of pain perception and anxiety during the administration of local anesthesia using three different injection techniques in 6 to 13 year old children- 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  Charul Anil Mahajan 
Designation  Post-Graduate Student in Pediatric Dentistry 
Affiliation  MGVs K.B.H Dental College and Hospital, Nashik(MUHS) 
Address  MGVs K.B.H Dental College and Hospital, First Floor, Department of Pediatric and Preventive Dentistry(605), Near Mumbai-Agra Highway, Panchvati, Nashik.

Nashik
MAHARASHTRA
422003
India 
Phone  8208708973  
Fax    
Email  charulmahajan15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Swapnil Kashinath Patil 
Designation  Professor and Head of the Department 
Affiliation  MGVs K.B.H Dental College and Hospital, Nashik(MUHS) 
Address  MGVs K.B.H Dental College and Hospital, First Floor, Department of Pediatric and Preventive Dentistry(605), Near Mumbai-Agra Highway, Panchvati, Nashik.

Nashik
MAHARASHTRA
422003
India 
Phone  9545178982  
Fax    
Email  dr.swapnilkpatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Charul Anil Mahajan 
Designation  Post-Graduate Student in Pediatric Dentistry 
Affiliation  MGVs K.B.H Dental College and Hospital, Nashik(MUHS) 
Address  MGVs K.B.H Dental College and Hospital, First Floor, Department of Pediatric and Preventive Dentistry(605), Near Mumbai-Agra Highway, Panchvati, Nashik.

Nashik
MAHARASHTRA
422003
India 
Phone  9545178982  
Fax    
Email  charulmahajan15@gmail.com  
 
Source of Monetary or Material Support  
MGVs K.B.H Dental College and Hospital, First Floor, Department of Pediatric and Preventive Dentistry(605), Near Mumbai-Agra Highway, Panchvati, Nashik-422003, Maharashtra, India. 
 
Primary Sponsor  
Name  Charul Anil Mahajan 
Address  MGVs K.B.H Dental College and hospital, first floor, Department of Pediatric and Preventive Dentistry, Panchvati, Nashik-422003. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Swapnil Patil  MGVs K.B.H Dental College and hospital, first floor, Department of Pediatric and Preventive Dentistry, Panchvati, Nashik-422003 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Charul Anil Mahajan  MGVs K.B.H Dental College and Hospital  MGVs K.B.H Dental College and Hospital, first floor, Department of Pediatric and Preventive Dentistry(605), Panchvati, Nashik-422003.
Nashik
MAHARASHTRA 		 8208708973

charulmahajan15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KBH 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: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Star Pen 2. Septodont  1- Star Pen- Dental Anesthesia Device(Woodpecker) using cartridge (Septodont- Lignospan special) and needle 30-guage (Septodont-Septojet) 2. Septodont- Aspirating syringe using cartridge (Septodont- Lignospan special) and needle 30-guage (Septodont-Septojet) Inferior alveolar nerve block will be administered, by using Single dose of 1.8 ml 2% lidocaine hydrochloride with adrenaline(1:80000)  
Comparator Agent  Conventional syringe and needle  Conventional method- using syringe 2ml (BD Emerald) and Needle 27 1/2 guage (DISPOVAN),Inferior alveolar nerve block will be administered, by using Single dose of 1.8 ml 2% lidocaine hydrochloride with adrenaline(1:80000) 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1.Patient with no prior history of local anesthesia administration for dental treatment procedure.
2. Cooperative behavior- class 3 or 4 Frankel scale.
3. Patients having dental problems related to mandibular molars.
4. No medical conditions contraindicating the use of local anesthesia.
5. Not taking any medications that potentially interfere with pain assessment within 24 hours before the treament. 
 
ExclusionCriteria 
Details  1. History of significant medical conditions.
2. Any medications.
3. Uncooperative patients.
4. Patients with cardiac pace-makers.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain perception during administration of local anesthesia using three different injection techniques is to be determined. Evaluation will take place using subjective scale by WONG BAKERS FACES PAIN RATING SCALE.  3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Anxiety during administration of local anesthesia using three different injection techniques is to be determined. Evaluation will take place using Venhams index.  3 Months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/04/2025 
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="3"
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 - 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 - Informed Consent Form
    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 - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  email ID- charulmahajan15@gmail.com

  6. For how long will this data be available start date provided 15-04-2025 and end date provided 15-06-2025?
    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 be conducted in the Department of Pediatric and Preventive Dentistry. The study will be conducted in children of age group of 6 to 13 years.  After comfortably seating the patient on a dental chair, the procedure will be explained to the parent as well as the children. 60 primary mandibular molars of 60 children fulfilling inclusion and exclusion criteria requiring dental procedures. In all patients, thorough history, clinical examination and preoperative radiographs will be taken. This study will be conducted using three different injection techniques in the children in the same appointments such that each child will serve as his or her own control.  These will be divided in three groups- Group A, Group B and Group C.  Group A- Star pen - Dental anesthesia device (Woodpecker) will be used for administration of local anesthetic solution and then dental procedures will be performed.  Group B- Septodont - Aspirating syringe will be used for administration of local anesthetic solution and then dental procedures will be performed.  Group C- Conventional technique using Syringe 2ml (BD EmeraldTM) and Needle 27 ½ -guage (DISPO VAN) will be used for administration of local anesthetic solution and then dental procedures will be performed. Treatment will be carried by operator(Pediatric Dentist). Pain perception score by Wong-Baker’s Faces Pain Rating Scale will be recorded by patient and anxiety score by Venham’s index will be recorded by investigator. The investigator is trained to record the Venham’s index score and he/she will be unaware of group assignment. Statistical analysis will be performed using Statistical Package for Social science (SPSS )version 21 for Windows (SPSSInc Chicago, IL). Quantitative ordinal data will be expressed in mean and standard deviation respectively. Data normality will be checked by using Shapiro – Wilk test. Confidence interval is set at 95% and probability of alpha error (level of significance) set at5%. Power of the study set at 80%. Overall intergroup comparison among three groups will be done using One-way Anova ‘F’ test followed by Tukey’s post hoc test for pairwise intergroup comparison between each groups.(if parametric). Overall intergroup comparison among three groups will be done using Kruskal Wallis test followed by Mann Whitney ‘U’ test for pairwise intergroup comparison between each groups. (if nonparametric) 
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