| CTRI Number |
CTRI/2025/02/081396 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare And Evaluate The Effectiveness Of Three Different Distraction Methods In Combating Children Dental Anxiety And Fear By Assessing Psychological And Physiological Parameters |
|
Scientific Title of Study
|
To Compare And Evaluate The Effectiveness Of Three Different Distraction Methods In Combating Children Dental Anxiety And Fear By Assessing Psychological And Physiological Parameters: A Randomized Clinical 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 |
Dr Manash Pratim Baruah |
| Designation |
Postgraduate |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8638291909 |
| Fax |
|
| Email |
baruahm68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Dhinsa |
| Designation |
Professor |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9721222260 |
| Fax |
|
| Email |
grover.kavita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Dhinsa |
| Designation |
Professor |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9721222260 |
| Fax |
|
| Email |
grover.kavita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Postgraduate Institute Of Dental and Medical Sciences,Chaudhary Vihar, Utrathia,
Raebareily Road,
Lucknow – 226025 – Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Manash Pratim Baruah |
| Address |
Department of Pediatric and Preventive Dentistry, Sardar Patel Post Graduate Institute of Dental and Medical Sciences
Chaudhary Vihar, Utrathia,
Raebareily Road,
Lucknow – 226025 – Uttar Pradesh, India |
| 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 |
| Dr Manash Pratim Baruah |
Sardar Patel Post Graduaqte Institute of Dental and Medical Sciences |
Department of
Pediatric and
Preventive Dentistry,
Department No.: 5,
Sardar Patel Post
Graduate Institute of
Dental and Medical
Sciences, Raebareli
Road, Vrindavan
Yojana, Lucknow, PIN-
226 025
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
8638291909
baruahm68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I- Visual-Distraction |
Chidren treated in the influence of Visual Distraction |
| Intervention |
Group- III- Audio Distraction |
Children treated in the influence of Audio Distraction |
| Comparator Agent |
Group- IV- Control Group |
Children treated under the influence of no specific behaviour modification |
| Intervention |
Group-II- Thaumaturgic Distraction |
Children treated in the influence of Thaumaturgic Distraction |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
i. Children within age group of 6-10 years, having their first dental visit.
ii. Children who fall under the American Society of Anaesthesiology (ASA) category I (defined as normal healthy patient).
iii. Guardians and Children who are willing to participate in the study.
iv. Children without any systemic and mental disorders.
v. Children who require oral prophylaxis treatment.
|
|
| ExclusionCriteria |
| Details |
i. Children with special healthcare needs.
ii. Guardians or children who refused to participate in the study.
iii. A child having carious or cavity lesion, in any of the teeth requiring restoration or any treatment other than oral prophylaxis.
iv. Emergency needs such as a drainage of abscess or extraction.
v. Children with a previous history of painful invasive dental procedures.
vi. Children who did not have parental consent.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected outcome in general, is to help combat dental anxiety and fear among children, so that they grow into adults who arent fearful of getting any dental treatment done on themselves in the future upon requirement |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expectation is to develop a society of individuals who donot fear and become anxious in the dental environment so as to have lower prevelance of dental problems in the future |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is basically being performed to compare the effectiveness of using three different behaviour modification techniques, to reduce dental anxiety and fear in children who are visiting a dental clinic for the first time. The three non-pharmacological methods of behaviour management being employed are: Visual-distraction, Thaumaturgic-distraction and Audio-distraction Anxiety levels in children will be assessed at baseline, before and after treatment, by the use of the Chotta Bheem Chutki Scale,Dental fear will be assessed at baseline, before and after treatment by the use of Traffic Light Color Codes and measurement of hemodynamic parameters ( oxygen saturation rate, heart rate, breathing rate and sweating), and biochemical analysis of salivary biomarkers (viz.- alpha amylase) from collected samples of unstimulated saliva.
|