| CTRI Number |
CTRI/2025/03/083013 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
"Checking if a three-sided toothbrush helps keep teeth cleaner than a regular toothbrush for young children with Autism in Hyderabad. |
|
Scientific Title of Study
|
Comparing the effectiveness of three sided toothbrush vs traditional toothbrush in maintenance of oral hygiene among 4-6 year old children with Autism spectrum disorder in Hyderabad city. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Kamble |
| Designation |
PG student |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY VIKARABAD |
| Address |
Room no 2
Department of Public Health Dentistry
Sri Sai College of Dental Surgery and Hospital
1-2-64/1 and 2,Kothrepally,opp.Shiv Sagar lake,Vikarabad Telangana
Room no 2
Department of Health Dentistry
Sri Sai College of Dental Surgery and Hospital
1-2-64/1 and 2,Kothrepally,opp.Shiv Sagar lake,Vikarabad Telangana
501102
Hyderabad
TELANGANA
501102
India |
| Phone |
09966777687 |
| Fax |
|
| Email |
drshwetaa7798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.M.Monica |
| Designation |
HOD and Professor (Public Health Dentistry)) |
| Affiliation |
Sri Sai College of Dental Surgery and Hospital 1-2-64/1 and 2,Kothrepally,opp |
| Address |
Sri Sai College of Dental Surgery and Research institute
1-2-64/1 and 2,Kothrepally,opp.Shiv Sagar lake,Vikarabad Telangana
Room no.2
Department of Public Health Dentistry
Sri Sai College of Dental Surgery and Research Institute
1-2-64/1 and 2,Kothrepally,opp.Shiv Sagar lake,Vikarabad Telangana
Hyderabad
TELANGANA
501102
India |
| Phone |
8008882912 |
| Fax |
|
| Email |
docmonica81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Kamble |
| Designation |
PG student |
| Affiliation |
Sri Sai College of Dental Surgery and Hospital 1-2-64/1 and 2,Kothrepally,opp |
| Address |
Room no 2
Department of Public Health Dentistry
Sri Sai College of Dental Surgery and Hospital
1-2-64/1 and 2,Kothrepally,opp.Shiv Sagar lake,Vikarabad Telangana
Room no 2
Department of Public Health Dentistry
Sri Sai College of Dental Surgery and Hospital
1-2-64/1 and 2,Kothrepally,opp.Shiv Sagar lake,Vikarabad Telangana 501102
Hyderabad
TELANGANA
501102
India |
| Phone |
09966777687 |
| Fax |
|
| Email |
drshwetaa7798@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 2
Department of Public Health Dentistry
Sri Sai College of Dental Surgery and Hospital
1-2-64/1 and 2,Kothrepally,opp.Shiv Sagar lake,Vikarabad Telangana |
|
|
Primary Sponsor
|
| Name |
Shweta kamble |
| Address |
Room no 2
Department of Public Health Dentistry
Sri Sai College of Dental Surgery and Hospital
1-2-64/1 and 2,Kothrepally,opp.Shiv Sagar lake,Vikarabad Telangana |
| 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 Shweta Kamble |
Ashoka Multi speciality Rehabilitation centre |
Room no 1.SRI NAGAR COLONY,MRO OFFICE,PLOT NO 15,OPPOSITE LANE TO KAPRA,SECUNDERABAD 500062
Hyderabad
TELANGANA |
09966777687
drshwetaa7798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE 2022-23E |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Toothbrush |
A standard,commercially available toothbrush with a single head and soft bristles |
| Intervention |
Three-Sided Toothbrush |
A specially designed toothbrush with three sides to facilitate easier and more efficient cleaning of teeth |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Mild to moderate ASD (autism spectrum disorder) children by using ISAA Scale score 70-153 |
|
| ExclusionCriteria |
| Details |
Severe autism cases.
Children having decayed tooth or root stumps |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque scores |
Baseline,3 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptability of toothbrush |
At Baseline
At 3 weeks & 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="3"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
People with autism spectrum disorder can experience many challenges that could affect their oral health status,including the need of assistance with core activities and barriers to quality health care.Factors that contribute to poor oral hygiene among this population include inadequate brushing technique,lack of caregiver training and adequate knowledge regarding the same ,so this study will be done to evaluate the effect of using a three-sided versus traditional toothbrush as an intervention to improve oral health of these children. |