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
|
|
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
|
|
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. |