| CTRI Number |
CTRI/2020/11/028862 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
29/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Specifically designed dental mobile application to improve the oral hygiene status of intellectually disabled children. |
|
Scientific Title of Study
|
Effect of specifically designed dental mobile application on oral hygiene status and Streptococcus mutans levels in dental plaque of intellectually disabled children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aayushi Sangal |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College and Hospital, Greater Noida |
| Address |
Department of Pedodontics,
ITS Dental College and Hospital
Knowledge Park 3, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9971377284 |
| Fax |
9971377284 |
| Email |
aayushisangal.i7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mousumi Goswami |
| Designation |
Head of Department, Department of Pedodontics |
| Affiliation |
ITS Dental College and Hospital, Greater Noida |
| Address |
Department of Pedodontics,
ITS Dental College and Hospital
Knowledge Park 3, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9971377284 |
| Fax |
9971377284 |
| Email |
mousumi87goswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aayushi Sangal |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College and Hospital, Greater Noida |
| Address |
Department of Pedodontics,
ITS Dental College and Hospital
Knowledge Park 3, Greater noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9971377284 |
| Fax |
9971377284 |
| Email |
aayushisangal.i7@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Dental College and Hospital, Greater Noida, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Aayushi Sangal |
| Address |
ITS DENTAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, KNOWLEDGE PARK 3, GREATER NOIDA, Uttar Pradesh |
| 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 |
| Aayushi Sangal |
ITS Dental College and Hospital, Greater Noida, Uttar Pradesh |
Department of Pedodontics and preventive dentistry
Gautam Buddha Nagar
UTTAR PRADESH |
9971377284
9971377284
aayushisangal.i7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S INSTITUTIONAL ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F79||Unspecified intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delivery of oral hygiene instructions via a specifically designed mobile application |
Oral hygiene instructions would be delivered to intellectually disabled children at baseline and then after 3 months via a mobile application specifically designed for them following which their oral hygiene status and Streptococcus mutant levels in their dental plaque samples would be assessed at 3 months and 6 months follow up. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group of 7-18yrs.
2) Cooperative intellectually disabled children
3) Intellectual disabilities included are :
a. Learning Disabled (LD)
b. Autism Spectrum Disorder (ASD)
c. Attention Deficit Hyperactive Disorder (ADHD)
4) DMFT/deft score of 2 and above.
|
|
| ExclusionCriteria |
| Details |
1) Definitely negative children (FRANKL TYPE I)
2) Parent consent not obtained.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in oral hygiene status of the children included in the study |
3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in the Streptococcus mutans levels in dental plaque samples of the children included in the study |
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1 |
|
Date of First Enrollment (India)
|
15/12/2020 |
| 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="8"
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
|
AIM: To evaluate the effect of a specifically designed dental mobile application on the oral hygiene status and Streptococcus mutans levels in dental plaque of intellectually disabled children. OBJECTIVES: To evaluate the improvement in oral hygiene status of intellectually disabled children after using the dental mobile application and to assess the Streptococcus mutans in dental plaque of intellectually disabled children at baseline and following the use of the dental mobile application at 3 months and 6 months. STUDY DESIGN: 90 intellectually disabled children (30 in each group - autistic, learning disabled and attention deficit hyperactivity disorder) in the age group of 7-18 years will be selected from the special schools of National Capital Region of India from where permission will be obtained and will be included in this study. Baseline evaluation of oral hygiene status and dental plaque sampling for assessment of Streptococcus mutans count will be done. Oral hygiene instructions will be delivered to them via video demonstrations in simple language through a specifically designed dental mobile application for them. Their caregivers will be instructed to show them the video everyday in the morning and at night before bedtime for 6 months. Oral hygiene status of these children as well as Streptococcus mutans levels in their dental plaque samples will be re-evaluated at 3 months and 6 months and the results will be subjected to statistical analysis. EXPECTED OUTCOMES: Improvement in the oral hygiene status and decrease in the Streptococcus mutans levels in dental plaque of intellectually disabled children after using the mobile application for 3 months and 6 months. |