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CTRI Number  CTRI/2024/12/078552 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Helping Kids with Autism: A Study on Toothbrushes to Reduce Plaque and Gum Issues 
Scientific Title of Study   Comparative Efficacy of Triple Headed toothbrush and Conventional single headed toothbrush in Reducing Plaque and Gingivitis in children and Adolescents with autism: 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  Biswadeep Roychowdhury 
Designation  Post Graduate 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum 
Address  Department of Public Health Dentistry, Department number 2, Ground Floor, KLE VK Institute of Dental Sciences, Belagavi.

Belgaum
KARNATAKA
590010
India 
Phone  7003891988  
Fax    
Email  biswadeepr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sagar Jalihal 
Designation  Reader 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum 
Address  Department of Public Health Dentistry, Department number 2, Ground Floor, KLE VK Institute of Dental Sciences, Belagavi.

Belgaum
KARNATAKA
590010
India 
Phone  9538843060  
Fax    
Email  drsagarjalihal@kledental-bgm.edu.in  
 
Details of Contact Person
Public Query  
Name  Biswadeep Roychowdhury 
Designation  Post Graduate 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum 
Address  Department of Public Health Dentistry, Department number 2, Ground Floor, KLE VK Institute of Dental Sciences, Belagavi.

Belgaum
KARNATAKA
590010
India 
Phone  7003891988  
Fax    
Email  biswadeepr@gmail.com  
 
Source of Monetary or Material Support  
KLE VK Institute of Dental Sciences, Nehru Nagar, JNMC Campus, Belgaum, Karnataka, India. PIN : 590010 
 
Primary Sponsor  
Name  KLE VK Institute of Dental Sciences 
Address  JNMC Campus, Nehru Nagar, Belgaum, Karnataka, Pin : 590010 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Gayatri Gawade  Ankur School  Department for Special Children, 335, Roy Road, Tilakwadi.
Belgaum
KARNATAKA 		 9743941303

gayatriphyde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Amities Foundation  No Objection Certificate 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Single Headed Toothbrush  Participants will receive their conventional single headed toothbrushes along with toothpaste at the start of the intervention phase. They will be instructed to brush twice daily under the supervision of their caregivers for a specified period 3 months. Follow-up visits will be scheduled 7th, 21st and 45th day to monitor compliance with the brushing regimen, reinforce proper brushing techniques, and address any issues that may arise during the study. 
Intervention  Triple headed toothbrush  Participants will receive their triple headed toothbrushes along with toothpaste at the start of the intervention phase. They will be instructed to brush twice daily under the supervision of their caregivers for a specified period of 3 months. Follow-up visits will be scheduled 7th, 21st and 45th day to monitor compliance with the brushing regimen, reinforce proper brushing techniques, and address any issues that may arise during the study. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1) Children with Autism Spectrum Disorder in the age range of 7 to 18 years who are attending special schools for children with autism in Belagavi, Karnataka, India
2) Children diagnosed with autism spectrum disorder, permanent or mixed dentition, cooperative children, and caregivers of children who assented and signed informed consent to participate in the study. 
 
ExclusionCriteria 
Details  Children with visual impairment, other special needs or challenges, and underlying systemic diseases, those with Frankl scale score less than 2 and uncooperative behavior, and other special health care needs, children who have received oral health education and treatment sessions in the last 12 weeks 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Implementing a triple-headed toothbrush in oral hygiene routines for children with autism can lead to more efficient and effective brushing, potentially improving both oral health and overall willingness to participate in brushing activities compared to conventional toothbrush.  Participants will receive their assigned toothbrushes along with toothpaste at the start of the intervention phase. They will be instructed to brush twice daily under the supervision of their caregivers for a specified period 3 months. Follow-up visits will be scheduled 7th, 21st and 45th day to monitor compliance with the brushing regimen, reinforce proper brushing techniques, and address any issues that may arise during the study. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Measure the time taken for each brushing session to assess if the triple-headed toothbrush reduces the time needed compared to the conventional single-headed toothbrush.
2) Evaluate the acceptability, comfort, and ease of use of the triple-headed toothbrush among children and adolescents with autism through feedback from participants and caregivers. 		 Participants will receive their assigned toothbrushes along with toothpaste at the start of the intervention phase. They will be instructed to brush twice daily under the supervision of their caregivers for a specified period 3 months. Follow-up visits will be scheduled 7th, 21st and 45th day to monitor compliance with the brushing regimen. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   03/01/2025 
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 Yet Recruiting 
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  

Primary Purpose of the Protocol:

The primary purpose of this protocol is to assess the efficacy of triple-headed toothbrushes compared to conventional single-headed toothbrushes in reducing plaque and gingivitis among children and adolescents with autism spectrum disorder (ASD). The randomized controlled trial aims to determine if the triple-headed toothbrush can provide superior oral hygiene outcomes, addressing the unique brushing challenges faced by individuals with ASD.

Study Hypothesis:

The triple-headed toothbrush is significantly more effective in reducing plaque and gingivitis in children and adolescents with autism compared to the conventional single-headed toothbrush.

 
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