| CTRI Number |
CTRI/2025/03/083569 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing three different brushing tools among 12 to 15 years Autism children in Madurai |
|
Scientific Title of Study
|
Evaluation of three different oral hygiene aids among 12 to 15 years Autism spectrum disorder children in Madurai - A Randomized control 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. Kaarthikeyan P S |
| Designation |
Post Graduate student |
| Affiliation |
Best Dental Science college |
| Address |
Department of Public health Dentistry,69/1 Ultra nagar chennai-madurai highway,madurai,tamilnadu
Madurai
TAMIL NADU
625104
India |
| Phone |
9944546691 |
| Fax |
|
| Email |
kaarthipskeyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Chavan |
| Designation |
Professor and Head |
| Affiliation |
Best Dental Science College |
| Address |
Department of Public Health Dentistry, Best dental science college, madurai
Madurai
TAMIL NADU
625104
India |
| Phone |
7975719960 |
| Fax |
|
| Email |
drsangeeta17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prem kumar P |
| Designation |
Reader |
| Affiliation |
Best Dental Science College |
| Address |
Department of Public Health Dentistry, Best dental science college, madurai
Madurai
TAMIL NADU
625014
India |
| Phone |
9042438114 |
| Fax |
|
| Email |
dentist.premkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Best Dental Science College,Ultra nagar,madurai-chennai highway, madurai , tamilnadu 625104. India |
|
|
Primary Sponsor
|
| Name |
Best Dental College Madurai |
| Address |
2,Ground floor,Department of public health dentistry,Best dental science college, Madurai 625104 |
| Type of Sponsor |
Other [Private Dental College 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 |
| Kaarthikeyan |
Bethsan Special School |
Second floor,
Room no 2,
Kovil Papakudi Rd, Thinam 4ani Nagar, Sikkandar Savadi, Koodal Nagar, Madurai, Tamil Nadu 625018
Madurai
TAMIL NADU |
9944546691
kaarthipskeyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Best Dental Science College |
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 |
| Comparator Agent |
Conventional toothbrush |
Colgate gentle sensitive toothbrush given to the participants with colgate strong toothpaste and asked to brush twice daily.Their caretakers were given health education and reinforcement and observed for 6 months |
| Intervention |
Electric tooth brush |
ORACURA SB200 Sonic lite Electric tooth brush given with colgate strong tooth paste and was asked to brush twice daily was given to caretakers along with health education and reinforcement and observed for 6 months |
| Intervention |
Waterflosser |
ORACURA OC 150 Lite SMART Waterflosser was given to autism children and instructed to caretakers how to use and insisted to use twice daily and health education and reinforcement given and observed for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female
Age group 12 to 15
MDPS A grade
Consent from parents/guardians
|
|
| ExclusionCriteria |
| Details |
Under Antiepileptics
Any systemic disease
No willingness
Chronic absentee
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral Hygiene Status using Oral hygiene simplified index, plaque index, gingival index. |
Baseline before using respective oral hygiene aid
1 month after using respective oral hygiene aid
3 months after using respective oral hygiene aid
6months after using respective oral hygiene aid |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in oral hygiene status |
1 month after using respective oral hygiene aid
3 months after using respective oral hygiene aid |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="6"
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
|
This study is a randomized parallel group trial comparing three different oral hygiene aids such as conventional toothbrush, Electric toothbrush and water flosser. Each group contains 15 Autism children. Brushing technique and oral health education is given to parents /caretakers and reinforced every month till the completion of the study. Baseline data collected using indices (such as plaque index, gingival index and oral hygiene index-simplified) and questionnaire to caretakers. Data collection using indices is done in 1st month , 3rd month and 6th month.Questionnaire is also collected during 6th month data collection. Questionnaire contains questions regarding attitude and practice of oral hygiene of autism children. From the datas collected we can come to a conclusion of which oral hygiene aid is better and we can extrapolate to all autism children. |