| 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
|
|
|
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
|
|
|
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. |