| CTRI Number |
CTRI/2025/08/092213 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Use of light and eye massager in children during dental treatment |
|
Scientific Title of Study
|
Comparative evaluation of tech-enhanced comfort in pediatric dentistry:the impact of photobiomodulation and sensory stimulation on pain and anxiety |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanisha S |
| Designation |
Post graduate student |
| Affiliation |
AMES Dental college and hospital |
| Address |
Department of Pedodontics
AMES dental college and hospital,raichur
Raichur KARNATAKA 584103 India |
| Phone |
8105431324 |
| Fax |
|
| Email |
tanishasnayaka@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Raghavendra Havale |
| Designation |
Vice principal head and professor |
| Affiliation |
AMES Dental college and hospital |
| Address |
Department of Pedodontics
AMES dental college and hospital,Raichur
Raichur KARNATAKA 584103 India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Tanisha S |
| Designation |
Post graduate student |
| Affiliation |
AMES Dental college and hospital |
| Address |
Department of Pedodontics
AMES dental college and hospital,raichur
Raichur KARNATAKA 584103 India |
| Phone |
8105431324 |
| Fax |
|
| Email |
tanishasnayaka@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMES Dental college and Hospital Raichur Karnataka INDIA 584103 |
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
Dr Tanisha S Department of pedodontics and preventive dentistry AMES Dental college and hospital raichur karnataka 584103 |
| Type of Sponsor |
Other [] |
|
|
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 Tanisha S |
Department of Pedodontics and Preventive Dentistry |
AMES Dental collge and Hospital,Raichur 584103 Raichur KARNATAKA |
8105431324
tanishasnayaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
reducing anxiety and pain during dental procedure |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 to 10 years old.
Children with first dental visit..
Children who need Local anaesthesia injection for their dental procedure.
Children with no prior exposure to dental anesthesia.
Children who do not have any neurological, psychological, or hearing impairments.
Children whose parents or guardians have provided informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Children who refuse to wear the device.
Children experiencing severe or acute dental pain.
Children with a past history of systemic or psychiatric disorders.
Children with definitely negative rating on the Frankl Behavioral .
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in anxiety and pain in children during dental treatment using PBM and eye massager |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 4 |
|
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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study will include 30 children aged 6–10 years attending their first dental visit at the Department of Pediatric and Preventive Dentistry. After enrollment, each child will be introduced to the operator and assessed for cooperative behavior using the Frankl Behavior Rating Scale to determine eligibility. Baseline measurements will be recorded, including subjective anxiety (RMS-PS) objective anxiety (Facial Image Scale) oxygen saturation and pulse rate. Participants will be randomly divided into two groups (n 15). Group I will receive Periorbital Eye Massager (PEM) therapy with natural sounds, while Group II will undergo Intranasal Photobiomodulation (IPBM). A crossover design will be implemented, where each group receives the alternate intervention during the second visit.
Pain experienced during local anesthesia will be assessed using the Faces Pain Scale – Revised (FPS-R). Additionally, cooperative behavior, pulse rate, and oxygen saturation will be monitored before and after each procedure. Children’s anxiety will also be assessed pre- and post-operatively using a validated, language-appropriate questionnaire to ensure accurate and culturally sensitive reporting. All the obtained data will be statistically analysed using paired t test. |