CTRI

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CTRI Number

CTRI/2025/03/082795 [Registered on: 19/03/2025] Trial Registered Prospectively

Last Modified On:

18/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Preventive
Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparing Triple-Headed and Single-Headed Toothbrushes for Better Oral Health in Visually Impaired Children and Teens in Belagavi: A Study on Plaque and Gingivitis Reduction

Scientific Title of Study

Assessing the Efficacy of Triple-Headed versus Conventional Single-Headed Toothbrushes in Reducing Plaque and Gingivitis Among Visually Impaired Children and Adolescents in Belagavi city: RCT

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	The Department of Public Health Dentistry is located on the ground floor, Department Number 2, at the KLE VK Institute of Dental Sciences in 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
Address	The Department of Public Health Dentistry is located on the ground floor, Department Number 2, at the KLE VK Institute of Dental Sciences in Belagavi. Belgaum KARNATAKA 590010 India
Phone	9538843060
Fax
Email	drsagarjalihal@kledental-bgm.edu.in

Details of Contact Person
Public Query

Name	Sagar Jalihal
Designation	Reader
Affiliation	KLE VK INSTITUTE OF DENTAL SCIENCES
Address	The Department of Public Health Dentistry is located on the ground floor, Department Number 2, at the KLE VK Institute of Dental Sciences in Belagavi. Belgaum KARNATAKA 590010 India
Phone	9538843060
Fax
Email	drsagarjalihal@kledental-bgm.edu.in

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
Dr Anita Gawade	The Maheshwari School for Blind	Department of Secondary Education, Room Number 2, Ground Floor, Nehru Nagar, Belagavi. PIN: 590010 Belgaum KARNATAKA	9448954235 msakthikarthi@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
Institutional Research and Ethics Committee KLE VKIDS	Approved
The Maheshwari School for Blind	No Objection Certificate

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	Visually impaired children and adolescent having permanent or mixed dentition, cooperative, and caregivers of those who assented and signed informed consent to participate in the study.

ExclusionCriteria

Details

Children with special needs or challenges other than visual impairment 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 OHE 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 visually impaired children 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 of 3 months. Follow-up visits will be scheduled on 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 visually impaired children and adolescents 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)

29/03/2025

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

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 visually impaired children and adolescents. 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 visually impaired individuals.

Study Hypothesis:

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