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CTRI Number  CTRI/2024/06/069004 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 12/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment in children without injection 
Scientific Title of Study   Neuromodulation As An Alternative To Local Anaesthesia Injections In Paediatric Patients With MIH- A Split Mouth Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhawna Saxena 
Designation  Post Graduate Student 
Affiliation  I.T.S Dental College Hospital and Research Centre  
Address  Room No 9, 4th Floor, Department of pediatric & Preventive dentistry, ITS dental college hospital & Research centre, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201308 India

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  9769892051  
Fax    
Email  dr.bhawnasaaxena@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mousumi Goswami 
Designation  Prof & Head 
Affiliation  I.T.S Dental College Hospital and Research Centre  
Address  Room no 9 fourth floor I.T.S. Dental college hospital and research centre, 47,knowledge park III, greater noida, uttar pradesh Gautam Buddha Nagar UTTAR PRADESH 201308 India

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  8588854190  
Fax    
Email  mousumi87goswami@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mousumi Goswami 
Designation  Prof & Head 
Affiliation  I.T.S Dental College Hospital and Research Centre  
Address  Room no 9 fourth floor I.T.S. Dental college hospital and research centre, 47,knowledge park III, greater noida, uttar pradesh Gautam Buddha Nagar UTTAR PRADESH 201308 India


UTTAR PRADESH
201308
India 
Phone  8588854190  
Fax    
Email  mousumi87goswami@gmail.com  
 
Source of Monetary or Material Support  
ITS Dental College Hospital & Research Centre, 47, knowledge park III, Greater Noida, UTTAR PRADESH, 201308 
 
Primary Sponsor  
Name  ITS Dental college hospital and research centre  
Address  Room no 9 fourth floor I.T.S. Dental college hospital and research centre, 47,knowledge park III, greater noida, uttar pradesh 201308  
Type of Sponsor  Research institution and hospital 
 
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 Bhawna Saxena  ITS DENTAL COLLEGE GN   Room No 9, 4th Floor, Department of pediatric & Preventive dentistry, ITS dental college hospital & Research centre,47 knowledge park III greater noida uttar pradesh Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 
9769892051

dr.bhawnasaaxena@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.T.S. DENTAL COLLEGE HOSPITAL & 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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anesthesia will be acieved using Neuromodulation device- Synapse dental pain eraser   Neuromodulation to be applied before starting the dental procedure for 60 sec each that is 3 min in total as follows- 60s on buccal surface 60s on palatal/lingual surface 60s on occlusal  
Comparator Agent  Local anesthesia injection using needle and lignocaine hydrochloride local anesthetic agent will be injected using suitable infiltration/block  Local Anesthesia using 2% Lignociane Hydrochloride and Adrenaline will be given prior to the procedure for achieving anesthesia for entire duration of treatment 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Patients with MIH with Bilateral Molars which are indicated for pulpotomy

2. FR Behavior rating 3 & 4

3. ASA I & II
 
 
ExclusionCriteria 
Details  1.Known neurological disorders.

2.Allergies to local anesthetics.

3.Contraindications to neuromodulation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of neuromodulation as an anesthetic agent
Comparative evaluation of neuromodulation and local anesthesia injection  
Pain-
1. At baseline
2. During Procedure
3. After Procedure
 
 
Secondary Outcome  
Outcome  TimePoints 
Patient acceptance & preference  1. Immediately after treatment
 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   25/06/2024 
Date of Study Completion (India) 30/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
In pediatric dentistry, pain and anxiety due to injections or local anesthetics play a significant role in the development of negative behaviors and pose challenges in the management and treatment of young patients. This issue is further complicated by developmental defects like Molar Incisor Hypomineralization (MIH), which makes achieving effective anesthesia particularly difficult due to high tooth hypersensitivity. These challenges necessitate continuous research into alternative anesthesia and pain management modalities for MIH.

Transcutaneous Electrical Nerve Stimulation (TENS) or neuromodulation has shown promise in providing dental anesthesia or serving as an adjunct to local anesthesia. However, conventional devices using electric pads can exacerbate anxiety. Neuromodulation, based on the gate control theory and neuropeptide release, offers a potential solution. It can enhance or replace local anesthesia, reducing the need for repeated anesthetic injections and minimizing needle prick anxiety by either decreasing the sensation of the prick or eliminating the need for needle anesthesia altogether. This approach aims to deliver a more comfortable and pain-free dental experience for children with MIH. 
 
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