| CTRI Number |
CTRI/2023/05/053162 [Registered on: 26/05/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of audio visual aids and conventional distraction techniques on pain and dental anxiety during dental treatment in children |
|
Scientific Title of Study
|
Comparative evaluation of pain and dental anxiety with the use of virtual reality distraction and conventional behaviour management in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashaswini B P |
| Designation |
Postgraduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital RGC campus Hebbal R T Nagar Post BANGALORE
Bangalore
KARNATAKA
560032
India |
| Phone |
9945355311 |
| Fax |
|
| Email |
ypyashasb62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh T Paul |
| Designation |
Professor and Head |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital RGC campus Hebbal R T Nagar Post BANGALORE
Bangalore
KARNATAKA
560032
India |
| Phone |
9972598341 |
| Fax |
|
| Email |
santhosht77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashaswini B P |
| Designation |
Postgraduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital RGC campus Hebbal R T Nagar Post BANGALORE
Bangalore
KARNATAKA
560032
India |
| Phone |
9945355311 |
| Fax |
|
| Email |
ypyashasb62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
|
|
Primary Sponsor
|
| Name |
Yashaswini B P |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital RGC campus Hebbal R T Nagar Post Bangalore Karnataka 560032 |
| 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 |
| Yashaswini B P |
Sri rajiv gandhi college of dental sciences and hospital |
Department of Pediatric and Preventive Dentistry rgc campus
cholanagar RT nagar hebbal 500032
Bangalore
KARNATAKA |
9945355311
ypyashasb62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Sri Rajiv Gandhi College of Dental Sciences and Hospital Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children of age 6 to 10 years with dental caries requiring restoration |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Behaviour therapy |
Distraction techniques of communication would be used while doing the restorative procedure for a duration of 1 hour |
| Intervention |
Virtual reality eyeglasses |
Virtual reality eyeglasses would be used as a distraction technique while doing restorative procedure under parent’s supervision for a duration of 1 hour |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children with no prior history of dental treatment.
Subjects and parents willing to give informed consent.
Subjects requiring restorative treatment.
Subjects scoring 3 or 4 on the Frankl’s Behaviour Rating Scale.
|
|
| ExclusionCriteria |
| Details |
Subjects with physical/mental/developmental disorders.
Subjects with Claustro-Phobia and Epilepsy.
Subjects with Salivary Gland Disorders.
Subjects that require local anesthesia administration for restoration.
Subjects scoring 1 or 2 on the Frankl’s Behaviour Rating Scale.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced dental anxiety |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better coping to get dental treatment |
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial is a randomised controlled, double blinded,
parallel group trial evaluating pain perception, pulse rate, oxygen saturation,
salivary pH as a measure of dental anxiety. Written informed consent from
parents /caretakers would be taken. Children of 6 to 10 years of age would be
recruited from the patients visiting the Department of Pediatric and Preventive
Dentistry of Dental college in Bangalore where ethical clearance has been
obtained. Pulse rate and oxygen saturation are assessed using a pulse oximeter
at three intervals, preoperatively, intraoperative and postoperatively.
Salivary pH will be assessed from the patient’s saliva sample collected at two
intervals, preoperatively and postoperatively, by a digital pH meter. The
children will be randomly allocated into two groups, VR group, who will receive
restorative treatment while being subjected to VR videos on the eyeglasses and
the other group will receive restorative treatment while distracted by means of
communication. The primary outcome would be reduced dental anxiety and
secondary outcome would be increased coping towards dental treatment. |