| CTRI Number |
CTRI/2025/07/090509 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of three distraction methods in children while administrating local anesthesia. |
|
Scientific Title of Study
|
Comparative Evaluation Of Distraction Cards, Virtual Reality Glasses And Precooling Vibrating Device As Distraction Methods In Children During Administration Of Inferior Alveolar Nerve Block- A Randomized Control 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 |
Deepshikha Behera |
| Designation |
Post Graduate Student |
| Affiliation |
Surendera Dental College and Research Institute |
| Address |
Department of pediatric and preventive dentistry, room number 06, Surendera Dental College and Research Institute, His highness gardens, powerhouse road, SriGanganagar, Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
7980241309 |
| Fax |
|
| Email |
drdeepshikhabehera0606@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suruchi Juneja Sukhija |
| Designation |
Professor and head |
| Affiliation |
Surendera Dental College and Research Institute RI |
| Address |
Department of pediatric and preventive dentistry, Surendera Dental College and Research Institute, His highness gardens, powerhouse road, Sriganganagar, Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9829365880 |
| Fax |
|
| Email |
drsuruchijuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepshikha Behera |
| Designation |
Post Graduate Student |
| Affiliation |
Surendera Dental College and Research Institute |
| Address |
Department of pediatric and preventive dentistry, room number 06, Surendera Dental College and Research Institute, His highness gardens, powerhouse road, Sriganganagar, Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
7980241309 |
| Fax |
|
| Email |
drdeepshikhabehera0606@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry, Surendera Dental College And Research Institute, HH gardens, Powerhouse Road, Sriganganagar, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Deepshikha Behera |
| Address |
Department of pediatric and preventive dentistry, Room number 06, Surnedera Dental College And Research Institute, HH gardens, Powerhouse road, Srigangangar, Rajasthan-335001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Deepshikha Behera |
Surendera Dental College And Research Institute |
Department of pediatric and preventive dentitry, room number 06, Surendera Dental College And Research Institute, His highness gardens, Powerhouse road, Sriganganagar
Ganganagar
RAJASTHAN |
7980241309
drdeepshikhabehera0606@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SURENDERA DENTAL COLLEGE & RESEARCH INSTITUTE ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Distraction Cards. |
Distraction Cards will be use as distraction methods during inferior alveolar nerve block. |
| Intervention |
Precooling vibrating device |
Precooling vibrating device will be use as distraction methods during inferior alveolar nerve block. |
| Comparator Agent |
Routine inferior alveolar nerve block administration |
No distraction methods will be use during inferior alveolar nerve block. |
| Intervention |
Virtual reality glasses |
Virtual reality glasses will be use as distraction methods during inferior alveolar nerve block. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 4-8 years requiring routine dental procedure to be carried out under inferior alveolar nerve block. Children who Children had not received local anesthesia before. Children not allergic to topical anesthesia. Presence of pulpaly involved teeth where need of extraction or pulpal therapy necessisating a nerve block. No history of systemic illness. |
|
| ExclusionCriteria |
| Details |
Children who had previously received local anesthesia. Children who presented with a history of chronic illness. Children who required treatment under sedation / general anesthesia. Visual, audio or speech impairments. Children allergic to local anesthesia |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of distraction cards, virtual reality glasses and precooling vibrating devices in reducing anxiety levels, pain perception and improving behavior during inferior alveolar nerve block. |
During inferior alveolar nerve block procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of anxiety levels, pain perception & behavior during inferior alveolar nerve block using distraction card, virtual reality glasses & precooling vibrating device |
Before & After admistration of inferior alveolar nerve block. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/08/2025 |
| 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="2"
Months="0"
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
|
The study
will use distraction methods in
children of age 4-8 years requiring administration of inferior alveolar nerve block.
Distraction cards, virtual reality glasses and precooling vibrating device will
be used as distraction methods. By using this distraction method anxiety
levels, behavior and pain perception will be assessed by Modified Child
Dental Anxiety Scale (MCDAD(f)); Venham’s Behavior Rating Scale; Face,
Legs, Activity, Cry, Consolability Scale (FLACC); Wong Baker FACES Pain Rating
Scale (WBFPRS) will be used prior to and
during local anesthesia administration. |