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CTRI Number  CTRI/2024/05/068068 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Dentistry
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Improving Dental Pain Relief for Kids with Molar Hypomineralization using a new device 
Scientific Title of Study   Neuromodulation as an Adjunct to Local Anaesthesia in Paediatric Patients with MIH- A Pilot Study 
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 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 
Phone  9769892051  
Fax    
Email  dr.bhawnasaxena@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 
Phone  9769892051  
Fax    
Email  MOUSUMI87GOSWAMI@GMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  Dr Bhawna Saxena 
Designation  Post Graduate Student 
Affiliation  I.T.S Dental College Hospital and Research Centre  
Address  I.T.S. Dental college hospital and research centre, 47,knowledge park III, greater noida, uttar pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  9769892051  
Fax    
Email  dr.bhawnasaxena@gmail.com  
 
Source of Monetary or Material Support  
Room no 9 fourth floor I.T.S. Dental college hospital and 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 
9769892051

dr.bhawnasaxena@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: K004||Disturbances in tooth formation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Local Anesthesia using 2% Lignociane Hydrochloride and Adrenaline  Local Anesthesia using Nerve Block will be given for anesthetizing the tooth (Molar or Incisor) undergoing dental treatment and affected by MIH Anesthesia will be provided for the entire duration of treatment once injected duration injection of anesthesia - over a maximum period of one minute  
Intervention  Neuromodulation using Synapse dental pain eraser, LA if required  Neuromodulation using Synapse Dental Pain Eraser will be done to acheive anesthesia in molars and Incisors affected by MIH and requiring local anesthesia for the treatment. If the anesthesia is not achieved then the Local Anesthesia using 2% Lignocaine Hydrochloride with adrenaline will be injected duration- 1minute on each surface (buccal, lingual and occlusal) total duration- 3 min and if required 3 min again  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  ASA I or II
Children aged 6-12 years.
Diagnosed with Molar Incisor Hypomineralization (MIH).
Requiring dental treatment under local anesthesia in either permanent molars or incisors.
 
 
ExclusionCriteria 
Details  Known neurological disorders.
Allergies to local anesthetics.
Contraindications to neuromodulation. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
-Reduction in Pain/Hypersensitivity
-Onset and Achievement of Anesthesia
-Patient Acceptance
-Duration of Anesthesia 
At baseline
at start of treatment
at end of treatment
duration of anesthesia will be measured after 30 minutes from intervention
after 60 minutes form intervention 
 
Secondary Outcome  
Outcome  TimePoints 
-Patient Acceptance
-Duration of Anesthesia 
immediately post treatment
30 min post 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)   10/06/2024 
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  
### 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.
hence a pilot study is taken up to evaluate and extend the basis for further research in this field. 
 
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