| CTRI Number |
CTRI/2024/04/065695 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Hush and comfort with Active noise cancellation |
|
Scientific Title of Study
|
Effect of active noise cancellation on dental anxiety and discomfort during dental procedure in 5-8 year old children |
| 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 Jasmin Winnier |
| Designation |
Associate Professor |
| Affiliation |
D. Y. Patil university, School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9773284371 |
| Fax |
|
| Email |
drjaswinnie@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kruti |
| Designation |
Post Graduate student |
| Affiliation |
D. Y. Patil university, School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9662373732 |
| Fax |
|
| Email |
ruhi182804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmin Winnier |
| Designation |
Associate Professor |
| Affiliation |
D. Y. Patil university, School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9773284371 |
| Fax |
|
| Email |
drjaswinnie@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Dr. D. Y. Patil Deemed to be University School of Dentistry, Sector 7, Highway Road, Neural, Navi Mumbai, Maharashtra, 400706 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Deemed to be University School of Dentistry |
| Address |
Dr. D. Y. Patil Deemed to be University School of Dentistry Sector 7, Highway Road, Neural, Navi Mumbai, Maharashtra, 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 J Jasmin Winnier |
Dr. D. Y. Patil Deemed to be University School of Dentistry |
Postgraduate clinic, Department of Pediatric and Preventive dentistry, Dr. D. Y. Patil Deemed to be University School of Dentistry, Sector 7, Highway Road, Nerul, Navi Mumbai, Maharashtra, 400706
Mumbai (Suburban)
MAHARASHTRA |
9773284371
drjaswinnie@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethical board, D. Y. Patil Deemed to be University School of Dentistry, Navi Mumbai. |
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 |
Active Noise Cancellation |
active noise cancellation was performed using headphones during ultrasonic scaling and restoration in children until the treatment is completed in 15-20 minutes |
| Comparator Agent |
No Noise cancellation |
ultrasonic scaling and restoration was performed under standard conditions without active noise cancellation for 15-20 minutes, until the treatment is completed |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in the age of 5-8 years
2. No systemic disease
3. No learning disability
|
|
| ExclusionCriteria |
| Details |
1.Children with complaint of pain, extraoral or intraoral abscess
2. Uncooperative child - Frankl’s rating 1 and 2
3. Patient with trauma.
4. History of any other medical conditions and children with special healthcare needs.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety and discomfort reduction was evaluated after standard treatment using the Visual Analog Scale and Facial Image Scale |
5 minutes after treatment completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| anxiety & discomfort reduction was evaluated after standard treatment using the visual analogue scale & facial image scale |
During the treatment |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
26/04/2024 |
| 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="3"
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
|
Studies indicate that dental anxiety is a significant concern, with 50% of females and 29% of males avoiding dental visits due to fear. Among subjects aged 6-11 years, 38% reported discomfort with the noise in the dental clinic. Over 60% of individuals felt varying degrees of annoyance in dental clinics, leading to conclude that clinic noise significantly contributes to anxiety and avoidance of dental treatment.
Oral prophylaxis often involves the use of an ultrasonic scaler and suction. Scaling operationgenerates noise upon activation, intensifying when it contacts the teeth. This noise factor can contribute to patient discomfort and anxiety during dental procedures.
Considering the importance of managing anxiety in kids during dental visits, it’s crucial to explore ways that help in behavior management. This study aims to evaluate if using noise cancellation can help reduce behavioral and anxiety issues in children during dental treatment. Understanding the impact of clinic noise, especially during procedures using tools like ultrasonic scalers, suction, and dental handpieces, is essential to improve the overall dental experience for patients, especially children. |