FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082415 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 15/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of a Neuromodulation Device and Topical Anesthetic for Reducing Pain and anxiety Before Local Anesthesia in Children 
Scientific Title of Study   Comparative evaluation of the effectiveness of a neuromodulation device and conventional topical anesthetic agent prior to local anesthesia administration in children: A randomised controlled clinical 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 PRABHLEEN KAUR 
Designation  Post Graduate Student 
Affiliation  ITS Dental College Hospital and Research Centre 
Address  Room number 9, Department of Paediatric and Preventive Dentistry ITS Dental College Hospital and Research Centre 47, Knowledge Park-III Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  6397776526  
Fax    
Email  prabhleendec1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ADITYA SAXENA 
Designation  Professor Department of Paediatric and Preventive Dentistry  
Affiliation  ITS Dental College Hospital and Research Centre 
Address  Room number 9, department of Paediatric and Preventive Dentistry, ITS Dental College Hospital and Research Centre 47, Knowledge Park-III Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  8527969884  
Fax    
Email  adisaxen85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ADITYA SAXENA 
Designation  Professor Department of Paediatric and Preventive Dentistry  
Affiliation  ITS Dental College Hospital and Research Centre 
Address  Room number 9, Department of Paediatric and Preventive Dentistry, ITS Dental College Hospital and Research Centre 47, Knowledge Park-III Greater Noida


UTTAR PRADESH
201310
India 
Phone  8527969884  
Fax    
Email  adisaxen85@gmail.com  
 
Source of Monetary or Material Support  
ITS Dental College Hospital and Research Centre 47, Knowledge Park-III Greater Noida, Uttar Pradesh, India Pin-201310 
 
Primary Sponsor  
Name  ITS Dental College Hospital and Research Centre 
Address  Room number 9, Department of Paediatric and Preventive Dentistry ITS Dental College Hospital and Research Centre 47, Knowledge Park-III Greater Noida, Uttar Pradesh, India Pin- 201310 
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 
Dr Prabhleen Kaur  ITS Dental College Hospital and Research Centre  Room number 9, Department of Paediatric and Preventive Dentistry ITS Dental College Hospital and Research Centre 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 
6397776526

prabhleendec1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ITS Dental College Hospital and Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lignocaine jelly  Application of dental synapse pain eraser for 40 seconds on off mode to act as placebo and avoid bias at the site of needle insertion. 2% lignocaine jelly will be applied for 2 minutes at the site where 2% local anesthesia injection has to be given. 2mL of local anesthesia will be administered through infiltration.  
Intervention  Neuromodulation Device  A wet cotton will be used at the site of needle insertion to mimic lignocaine jelly application. Synapse dental pain eraser will be used for 40 seconds at the site where 2% local anesthesia injection has to be given. 2mL of local anesthesia will be administered through infiltration.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1- Patients in ASA-I and ASA-II category.
2- Patients who are indicated for primary teeth extraction.
3- Patients in the 6-10 yrs of age group.
4- Children with Frankel Behaviour ratings 3 and 4.
 
 
ExclusionCriteria 
Details  1- Patients with known allergy to any component of local anesthesia.
2- Patients with special health care needs
3- Patients unwilling to be a part of this study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain and anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), and Respiratory Rate (analyzed manually)
 
At baseline, during needle insertion and local anesthesia deposition 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of pain & anxiety in child will be measured using- Wong-Baker Faces Pain Rating Scale (WBFPRS), FLACC Scale (Face, Legs, Activity, Cry, Consolability) Pain Assessment Tool, Salivary pH (collected from unstimulated saliva by drooling method), Pulse rate (using a pulse oximeter), & Respiratory Rate (analyzed manually)
 
At baseline, during needle insertion & local anesthesia deposition 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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/ Phase 4 
Date of First Enrollment (India)   28/08/2025 
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  

Pain in children during dental procedures can cause significant anxiety, leading to dental phobia and avoidance of necessary treatment. Local anesthesia (LA) is essential for pain management in pediatric dentistry but is often associated with fear due to the use of needles. This fear can lead to increased anxiety, abnormal physiological responses, and resistance to treatment.

Various methods have been explored to minimize pain during LA administration, including behavioral techniques, topical anesthetics, and advanced delivery systems like computerized injectors. Among these, topical anesthetics are widely used due to their ease of application and ability to reduce needle-related pain. However, they may have limitations such as delayed onset, unpleasant taste, or allergic reactions.

Neuromodulation devices, such as the Dental Pain Eraser, offer a promising alternative by delivering mild electrical impulses to block pain signals and stimulate natural pain relief. These devices have shown effectiveness in reducing pain and anxiety during various dental procedures, including orthodontic treatments and extractions. Compared to conventional transcutaneous electrical nerve stimulation (TENS) devices, which can be bulky and uncomfortable, portable neuromodulation devices provide a more patient-friendly approach.

This study aims to evaluate and compare the effectiveness of a neuromodulation device and a topical anesthetic agent in reducing pain and anxiety before local anesthesia administration in children undergoing primary teeth extraction. The findings could help establish a more comfortable and efficient pain management strategy in pediatric dentistry, reinforcing positive dental experiences.

 
Close