| CTRI Number |
CTRI/2024/05/066902 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Medical Device
Surgical/Anesthesia
Screening
Dentistry
Behavioral
Other (Specify) [Distraction using audio visual aids and virtual reality eyeglass] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparative evaluation of two different distraction techniques in dental anxiety and pain during maxillary infiltration and inferior alveolar nerve block administration |
|
Scientific Title of Study
|
Comparative evaluation of two different distraction techniques in dental anxiety and pain during maxillary infiltration and inferior alveolar nerve block administration among 6-11year old children |
| Trial Acronym |
PAT (Pain Anxiety Trial) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mary grace |
| Designation |
Post graduate |
| Affiliation |
Madha dental college and hospital |
| Address |
Department of Pediatric and Preventive dentistry, Madha dental college and hospital Somangalam main road Madha Nagar kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Chennai
TAMIL NADU
600069
India |
| Phone |
7401036221 |
| Fax |
|
| Email |
manickammonica@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun.E |
| Designation |
Head of the Department |
| Affiliation |
Madha dental college and hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Madha dental college and hospital Somangalam main road, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Chennai
TAMIL NADU
600069
India |
| Phone |
7401036221 |
| Fax |
|
| Email |
arunetam@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mary grace |
| Designation |
Post graduate |
| Affiliation |
Madha dental college and hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Madha dental college and hospital, Somangalam main road, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Chennai
TAMIL NADU
600069
India |
| Phone |
7401036221 |
| Fax |
|
| Email |
manickammonica@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Madha Dental college and Hospital, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069 |
|
|
Primary Sponsor
|
| Name |
Dr Mary Grace |
| Address |
No 17/9, Chidambaranar street, Ramana Nagar, Perambur, Chennai 600011 |
| Type of Sponsor |
Other [Dr Ashok Kumar] |
|
|
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 Mary graceS |
Madha dental college and hospital |
Department of Pediatric and Preventive Dentistry, Madha dental college and hospital, Somangalam main road, Madha nagar, kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Chennai
TAMIL NADU |
07401036221
manickammonica@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MADHA DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
virtual reality eye glass |
distraction using virtual reality eye glass (virtual reality box) Pansonite VR Headset for a duration of 25 minutes |
| Comparator Agent |
audio visual aid (television) |
Distraction using audio visual aids (television)
Philips 222 V8La 22 inch television for a duration of 25 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children displaying both positive and negative ratings according to Frankl behavior rating scale
Requirement for any dental treatment necessitating bilateral local anesthetic administration within a single arch
Consent obtained from childrens parents |
|
| ExclusionCriteria |
| Details |
Children with prior exposure of local anesthesia administration
Patients with medically or developmentally compromising conditions like epilepsy, photo sensitivity etc
Patients with mental or cognitive impairments
Children with language barriers
Children with known allergies to local anesthetic agents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce anxiety in children during local anesthetic administration |
The patient was assessed in 2 dental visits in a time gap of 2 weeks and the baseline, during procedure and after procedure values are noted |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce anxiety & to increase the cooperativeness of child during dental treatment |
The patient was assessed in 2 dental visits in a time gap of 2 weeks & the baseline, during procedure & after procedure values are noted |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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 present study is a comparative randomized crossover clinical trial conducted in vivo. This study was performed to assess the effectiveness of two different distraction techniques such as audio visual aids and virtual reality eye glasses during local anesthetic administration in children prior to their dental treatment. The children are divided into four groups each group had equal number of children based the frankl’s behavior rating scale (positive / negative). Group 1 and 2 children included children requiring bilateral maxillary posterior infiltrations while group 3 and 4 included children in need of bilateral inferior alveolar nerve block administration. The primary outcome of the study is to decrease anxiety and fear in children and to maintain a positive behavior of the child throughout the procedure. This study has 2 dental visits. During the first visit if the child is subjected to Audio visual aids the same child will be subjected to virtual reality eyeglass in its second visit. The anxiety, behaviour and pain will be assessed to different methods such as FLACC scale, Iowa pain thermometer-revised and pulse oximeter is used to measure the pulse rate of the child throughout the procedure |