| CTRI Number |
CTRI/2025/08/093838 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of manual and ionic tooth brushing on oral health and microbial status of individuals with intellectual disabilities. |
|
Scientific Title of Study
|
Comparative evaluation of manual and ionic tooth brushing on oral health and microbial status of individuals with intellectual disabilities. |
| 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 Rupali Kalsi |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Dentistry
Kasna
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9582422688 |
| Fax |
|
| Email |
rupalikalsimathur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Kalsi |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Dentistry
Kasna
Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
9582422688 |
| Fax |
|
| Email |
rupalikalsimathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukesh Kumar |
| Designation |
In-charge Clinical Trial Unit |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Clinical Trial Unit
Kasna
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9116161133 |
| Fax |
|
| Email |
ctu.gims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Research Unit
Government Institute of Medical Sciences (GIMS) |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences Greater Noida |
| Address |
Kasna
Greater Noida Gautam Buddha Nagar |
| Type of Sponsor |
Government 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 Rupali Kalsi |
Government Institute of Medical Sciences (GIMS) |
Department of Dentistry
Gautam Buddha Nagar
UTTAR PRADESH |
9582422688
rupalikalsimathur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GIMS Greater Noida |
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 |
| Intervention |
Ionic toothbrushes |
Intervention for 90 days |
| Comparator Agent |
Manual toothbrushes |
Intervention for 90 days |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both the genders with at least 20 erupted teeth.
2. Age group 7-30 years.
3.Subjects with mild to moderate degree of intellectual disability
|
|
| ExclusionCriteria |
| Details |
1.Subjects with systemic diseases.
2.Subjects who have received any antibiotic therapy in the last 1 months or subjects taking drugs that could affect state of gingival tissues including corticosteroids and non-steroidal anti-inflammatory drugs.
3. Subjects with true periodontal pockets.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To find out the efficacy of ionic toothbrushes over manual toothbrushes on gingival inflammation based on Gingival Index
2.To find out the efficacy of ionic toothbrushes over manual toothbrushes on plaques scores based on Plaque Index
3.To find out the efficacy of ionic toothbrushes over manual toothbrushes on reduction of oral microbiota .
|
From Baseline to end of treatment at the day 07,21,45,90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Qualitative in depth interviews will be taken of caregivers to explore the problems and barriers encountered with routine oral hygiene measures.
2. Compliance and comments about the brushes will be determined by a pre validated questionnaire based survey. The care giver survey will consist of nine-point Likert-type items to allow for ratings of comfort level, acceptability and usefulness of tooth brush. |
From Baseline to end of treatment at the Day 90. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="18"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Comparative
evaluation of manual and ionic tooth brushing on oral health and microbial
status of individuals with intellectual
disabilities. 1. To find out the efficacy
of ionic toothbrushes over manual toothbrushes on gingival inflammation based
on Gingival Index
2. To find out the efficacy
of ionic toothbrushes over manual toothbrushes on plaques scores based on
Plaque Index
3. To find out the efficacy of ionic
toothbrushes over manual toothbrushes on reduction of oral microbiota . Study proposes to
assess the effectiveness of ionic based tooth brushes in maintaining oral
hygiene; reducing gingivitis. A previous study showed that proportion of
subjects showing important difference of 44% clinically improvement on power
brushing as compared to normal brushing is acceptable. Qualitative in depth interviews will be taken of caregivers to explore
the problems and barriers encountered with routine oral hygiene measures.
One-to-one interviews will be used to get the personal, medical and demographic
data of the participants. Compliance and comments about the brushes will be
determined by a pre validated questionnaire based survey. The care giver survey
will consist of nine-point Likert-type items to allow for ratings of comfort
level, acceptability and usefulness of tooth brush. Participants will be asked
to provide open-ended feedback at the end of both the brusher and brushee
surveys. Consent for participating in
the study will taken from all volunteers. Instructions were given to use only
the given brushes twice daily for 3 minutes by the assigned tooth brushing
technique. Demonstration of tooth brushing technique will be given to all the
participants and their caregivers by live demonstration and educational videos
will be circulated.
|