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CTRI Number  CTRI/2025/05/087654 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study comparing different topical methods to reduce pain and anxiety in children during different dental injections 
Scientific Title of Study   Comparative evaluation of different pre-anesthetics efficacy in reducing pain perception and anxiety in children during different local anesthesia techniques: 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 HEENA POPTANI 
Designation  PG Student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Dept. of pediatric dentistry, Room no 108, first floor, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  7020931450  
Fax    
Email  poptaniheena2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR HEENA POPTANI 
Designation  PG Student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Dept. of pediatric dentistry, Room no 108, first floor, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  7020931450  
Fax    
Email  poptaniheena2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh N Bahadure 
Designation  Associate Professor 
Affiliation  Govt. Dental College and Hospital, Nagpur 
Address  Dept of Pediatric Dentistry, Room no 108, first floor, Government Dental College and Hospital, Nagpur, Govt medical campus, Hanuman nagar, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  8329998328  
Fax    
Email  mdsrakesh_pedo@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Dental College and Hospital, Hanuman Nagar, Medical square, Nagpur-440003 
 
Primary Sponsor  
Name  Dr Heena Poptani 
Address  Dept of Pediatric and Preventive Dentistry, Govt dental college and hospital, medical campus, Hanuman nagar, Nagpur 440003. 
Type of Sponsor  Other [Self funded] 
 
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 HEENA POPTANI  Government Dental College and Hospital, Nagpur  Department of Pediatric and Preventive Dentistry Room 108 First floor Government Medical Campus, Hanuman nagar Nagpur-440003
Nagpur
MAHARASHTRA 		 7020931450

poptaniheena2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GDCH Nagpur  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 
Intervention  Benzocaine gel 20%  Benzocaine gel is a topical anesthetic commonly used to numb the oral mucosa before administering local anesthesia. It provides temporary pain relief by blocking nerve signals at the application site. We aim to compare benzocaine with lignocaine as a pre-anesthetic method 
Intervention  Buzzy device  The Buzzy device is a non-pharmacological pain relief tool that combines vibration and cold to reduce pain and anxiety during local anesthesia injections. We aim to compare the buzzy device with gold standadr lignocaine spray as pre-anesthetic method 
Intervention  Cryotherapy  It involves applying ice pack or cold spray before injection to temporarily numb the area before giving dental injections. We aim to compare the cryotherapy with lignocaine as pre-anestheic method 
Comparator Agent  Infiltration anesthesia  Local infiltration is a dental anesthesia technique where the anesthetic solution is injected directly into the buccal or lingual vestibule near the target tooth. It numbs a small, localized area by blocking nerve endings at the injection site. This method is being used as a control to compare it with intraligamentary anesthesia 
Intervention  Intraligamentary anesthesia  This technique involves depositing the anesthetic solution into the coronal portion of the PDL, from where it reaches the alveolar bone. This method provides short duration anesthesia in localized area. We aim to compare the intraligamentray anesthesia with infiltration anesthesia which is the most commonly used method for providing LA in dentistry. 
Comparator Agent  Lignocaine spray 10%  Lignocaine has been the most commonly used pre-anesthetic agent since decades. It is available in gel and spray form and provides effective surface anesthesia within 1-3 minutes after its application. It is gold standard to compare all the other pre-anesthetic methods 
Intervention  Xylitol solution 30%  Xylitol solution is a sweet-tasting, sugar-free liquid commonly used in dentistry for its anticariogenic properties. it is used primarily for its sweet taste and soothing effect, which helps distract and calm children before administering local anesthesia. We aim to compare the xylitol solution with lignocaine as pre-anesthetic method 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Healthy children with no systemic illness, history of allergies• Positive and definitely positive Frankl behaviour rating scale
children
2.Children requiring administration of local anesthesia for dental
treatment.
3.Children with deep carious primary teeth in upper or
lower arch excluding primary mandibular second
molars
4.Consent provided by parent(s)/guardian(s).
5.Children with no previous experience of intraoral local anesthesia 
 
ExclusionCriteria 
Details  1.Children with known systemic illness
2.Negative and Definitely negative Frankel behaviour rating scale
children
3.Children less than 5 years of age
4.Children with deep carious primary mandibular second molars.
5.Children with known allergy to any of the components of local
anesthesia or any pre-anesthetic medication included in this
study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain and anxiety assessment using appropriate pain and anxiety scales  At baseline, 2 minutes, 5 minutes and 30 minutes after LA administration 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 3 
Date of First Enrollment (India)   31/05/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This is a prospective, randomized, interventional clinical trial. It aims to compare the efficacy of various pre-anesthetic agents i.e. lignocaine spray, benzocaine gel, buzzy device, cryotherapy, xylitol solution during two local anesthesia techniques i.e. intraligamentary and infiltration techniques. Pain management is important in pediatric dentistry for effective behaviour management and also for fostering positive long term attitude of child towards dental care. This study aims to determine the most comfortable local anesthesia technique for pediatric patients.
 
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