| CTRI Number |
CTRI/2025/07/091240 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Acceptance and preference of electronic anaesthetic device over conventional |
|
Scientific Title of Study
|
Acceptance and preference of local anaesthesia technique with Conventional and Electronic anaesthetic device -A comparative 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 |
Annlitta Felix |
| Designation |
Postgraduate |
| Affiliation |
The Oxford dental college |
| Address |
The Oxford dental college and hospital,Bommanahalli,Hongasandra
Bangalore
KARNATAKA
560068
India |
| Phone |
9037409315 |
| Fax |
|
| Email |
drannlittafelix@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharath Vardhana |
| Designation |
Reader |
| Affiliation |
The Oxford dental college |
| Address |
The Oxford dental college and hospital,Bommanahalli,Hongasandra
Bangalore
KARNATAKA
560068
India |
| Phone |
9886588595 |
| Fax |
|
| Email |
bharath.dentist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annlitta Felix |
| Designation |
Postgraduate |
| Affiliation |
The Oxford dental college |
| Address |
The Oxford dental college and hospital,Bommanahalli,Hongasandra
Bangalore
KARNATAKA
560068
India |
| Phone |
9037409315 |
| Fax |
|
| Email |
drannlittafelix@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford dental college, 10th Milestone, Bommanahalli,
Hosur Road, Bangalore - 560068,
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Annlitta Felix |
| Address |
The Oxford dental college,10th Milestone, Bommanahalli,
Hosur Road, Bangalore - 560068,
Karnataka, India |
| Type of Sponsor |
Other [Postgraduate Student] |
|
|
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 |
| Annlitta Felix |
The Oxford Dental College |
Dept of pediatric and preventive dentistry, 4th floor, bommanahlli, bangalore
Bangalore Rural
KARNATAKA |
9037409315
drannlittafelix@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional technique |
syringe method of local anesthesia delivery for 3 months |
| Intervention |
Starpen electronic anesthetic device |
electronically controlled local anesthesia delivery method for 3 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Requiring minor paediatric dental procedures on both sides of the dental arch.
Written consent from the parent
No cognitive impairment
|
|
| ExclusionCriteria |
| Details |
Special children with mental disabilities.
Children suffering from systemic disorders.
Unwilling and unaccompanied children.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Electronic dental anaesthetic device is better than conventional technique |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| conventional is better than electronic anesthetic device |
baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
08/08/2025 |
| 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="0"
Months="3"
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
|
Creating a positive dental experience for children relies on minimizing pain. Though effective, traditional anaesthetic injections often trigger anxiety. Alternatives like electronic dental anaesthesia (EDA), jet injectors, and topical agents aim to reduce this. |