| CTRI Number |
CTRI/2024/12/077631 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of Dental Anxiety in children using Multifaceted Distraction Technique during Local anaesthetic procedure. |
|
Scientific Title of Study
|
Assessment of Dental Anxiety in children by using Multifaceted Distraction Technique during Local anaesthetic procedure- A Prospective Clinical 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 |
Dr Janipalli Nikitha |
| Designation |
PG Student |
| Affiliation |
GITAM dental college and hospitals |
| Address |
Department Of Pedodontics ,GITAM Dental College, Gandhi nagar Campus,Rushikonda, Visakhapatnam ,Andhra Pradesh ,530045
India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9502883787 |
| Fax |
|
| Email |
jnikita.jnikita95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
GITAM dental college and hospitals |
| Address |
Department Of Pedodontics ,GITAM Dental College, Gandhi nagar Campus,Rushikonda, Visakhapatnam ,Andhra Pradesh ,530045
India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
GITAM dental college and hospitals |
| Address |
Department Of Pedodontics ,GITAM Dental College, Gandhi nagar Campus,Rushikonda, Visakhapatnam ,Andhra Pradesh ,530045
India
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pedodontics and Preventive Dentistry,
Room no 3,
GITAM Dental College and Hospital,
Visakhapatnam 530045 |
|
|
Primary Sponsor
|
| Name |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital, Rushikonda
Visakhapatnam, Andhra Pradesh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jayalakshmi Pandranki |
GITAM Dental College and Hospital |
Department Of Pedodontics ,GITAM Dental College, Gandhi nagar Campus,Rushikonda, Visakhapatnam ,Andhra Pradesh ,530045
India
Visakhapatnam
ANDHRA PRADESH |
09912860194
mds.deepthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GITAM Dental College and Hospital Visakhapatnam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K047||Periapical abscess without sinus, (2) ICD-10 Condition: K041||Necrosis of pulp, (3) ICD-10 Condition: K046||Periapical abscess with sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multifaceted distraction group (MFD) |
Children were introduced to the new multifaceted distraction tool made up of inflation bulb, hollow tube and a balloon. The patients were asked to press the inflation bulb in slow pace during the local anesthetic procedure which last for about 5 minutes to 10 minutes. The inflation bulb was connected to a medium size balloon placed at the eye level near dental operatory light handle with a hollow tube. The children were instruction to keep pressing the inflation bulb, focus on the blowing balloon, thereby engaging the child with visual distraction during administration of local anesthesia |
| Comparator Agent |
Virtual reality distraction group (VRD) |
Children will be given a few minutes to get accustomed to the VR headset (Jio, Shine Concept Limited, Dongguan, China) prior to the beginning of the treatment. During intervention, children will be given a choice of five non immersive cartoon movies to select and played and then LA was administered. The entire session will last for about 5-10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 3–7 years having their first dental visit.
2.A total score of revised Modified Children Dental Anxiety Scale - Face Version (MCDASf) ≥19 indicating dental anxiety.
3.Children classified under ASA I group (American Society of Anesthesiologists physical status classification) and no history of allergy to local anesthetic solutions.
4.Requiring inferior alveolar nerve block for primary tooth treatment.
5.Tooth free from periodontal inflammation or infection to ensure effective local anesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Children with neurobehavioral disorders.
2.Children with chronic systemic diseases.
3.Children with visual or auditory impairments.
4.Children sensitive to motion or flashing lights.
5.Children with injuries to the eyes, face, neck, or arms that hinder the effective use of a VR box.
|
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate
Partial pressure of oxygen
Salivary Cortisol levels |
Baseline and also after completion of the dental treatment (post-operatively) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Memoji pain scale
“HOUPT†behavior rating scale |
Scoring will be done on the same day at the end of the treatment |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Background:
In Pediatric Dentistry, a child’s emotional state greatly affects pain perception, and local
anesthesia can sometimes increase anxiety and pain. The emerging multifaceted
distraction (MFD) technique aims to engage and soothe children during dental
procedures. This study evaluates the efficacy of MFD in reducing pain and
anxiety during inferior alveolar nerve blocks (IANB) in children aged 4-7 years
and compared with Virtual Reality Distraction. Methods: Children
aged 3-7 with dental anxiety will be randomly selected using the Modified Faces
version of the MCDASf, with parental consent. They will be divided into two
groups: Group A – Virtual Reality Distraction (VRD) and Group B – Multifaceted
Distraction (MFD). Heart rate, SpO2, and salivary cortisol levels will be monitored before and after Local Anesthesia procedures. Pain and over
all behavior assessment of each child will be assessed using Memoji’s Pain Scale
and Houpt scale respectively after the procedure. The collected readings will be subjected to statistical
analysis using the Student’s paired t-test for intragroup comparisons and non-parametric
Mann-Whitney U test. |