| CTRI Number |
CTRI/2025/08/092295 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Exploring the role of color – changing toothpaste for improving children’s oral hygiene behavior |
|
Scientific Title of Study
|
Exploring the role of a novel color – changing toothpaste as an aid for improving children’s oral hygiene behavior: an in vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nithya Annie Thomas |
| Designation |
Reader |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pediatric and preventive dentistry, Manipal college of dental sciences, Manipal academy of Higher education
Manipal college of dental sciences, Madhav Nagar, Eshwar nagar
Udupi
KARNATAKA
576104
India |
| Phone |
8129773173 |
| Fax |
|
| Email |
nithya.thomas@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Nithya Annie Thomas |
| Designation |
Reader |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pediatric and preventive dentistry, Manipal college of dental sciences, Manipal academy of Higher education
Manipal college of dental sciences, Madhav Nagar, Eshwar nagar
Udupi
KARNATAKA
576104
India |
| Phone |
8129773173 |
| Fax |
|
| Email |
nithya.thomas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nithya Annie Thomas |
| Designation |
Reader |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Pediatric and preventive dentistry, Manipal college of dental sciences, Manipal academy of Higher education
Manipal college of dental sciences, Madhav Nagar, Eshwar nagar
Udupi
KARNATAKA
576104
India |
| Phone |
8129773173 |
| Fax |
|
| Email |
nithya.thomas@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Star Dental Care Private Limited |
| Address |
1st floor, ELDECO CENTRE, near Malviya Nagar metro station
Delhi, 110017
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Nithya Annie Thomas |
Manipal college of dental sciences |
Department of Pediatric and preventive dentistry, MCODS, Manipal
Udupi
KARNATAKA |
8129773173
nithya.thomas@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College/Kasturba Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy school children between the ages of 6-12 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
G1 |
Group 1 (G1) will receive a
colour-changing toothpaste that turns purple after 2 minutes to show that brushing is complete. A
demonstration of the correct brushing method (Modified Bass technique) will be provided to all
participants, and each child will receive their assigned toothpaste accordingly. The total duration of the
study is 10 weeks. During this period, the child will need to brush their teeth twice a day — once in
the morning and once in the evening — and record each brushing session in a log provided in the
booklet |
| Comparator Agent |
G2 |
Group 2 (G2), you will receive a
non colour changing toothpaste. A
demonstration of the correct brushing method (Modified Bass technique) will be provided to all
participants, and each child will receive their assigned toothpaste accordingly. The total duration of the
study is 10 weeks. During this period, the child will need to brush their teeth twice a day — once in
the morning and once in the evening — and record each brushing session in a log provided in the
booklet |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1- Healthy children with no systemic or medical conditions that would interfere with the
study
2- Parents/ caretakers who consent to their child’s participation in the study
3- Children able to brush independently
4- Children not undergoing any orthodontic treatment |
|
| ExclusionCriteria |
| Details |
1- Children with a history of allergic reactions to toothpaste ingredients
2- Children who have received extensive dental treatments during the study period |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1- Improved brushing techniques: Children using the color changing toothpaste are expected to show better plaque removal
2- Increased motivation: The colour changing feature is anticipated to make brushing more engaging and motivate children to brush consistently
3- Enhanced long term oral hygiene: We presume that the experimental group will maintain better oral hygiene habits over time, leading to improved oral health outcomes |
BASELINE, WEEK5, WEEK10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Brushing Frequency & Duration:
Self-reported brushing logs maintained by children/parents to monitor frequency (twice a day adherence) & brushing duration.
Long-Term Oral Hygiene Behaviour:
Evaluated via follow-up questionnaire responses & sustained plaque reduction trends, indicating formation of consistent habits.
User Satisfaction & Enjoyment:
Assessed through child & parent feedback at study conclusion, focusing on product experience, ease of use, & overall acceptability. |
Expected Result: Children using color-changing toothpaste will demonstrate better brushing compliance over time. |
|
|
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)
|
14/08/2025 |
| 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="4"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nithyaannie@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Maintaining sound oral health, particularly in children, is essential, as poor oral hygiene
can lead to a myriad of dental issues, including early childhood caries. However, many
children struggle with developing consistent and effective brushing habits, often due to
lack of motivation, poor comprehension of brushing techniques, and the monotony of the
chore. Ensuring children adopt and maintain proper oral hygiene practices is a significant
challenge for parents, caregivers and healthcare professionals.
An innovative approach to improving children’s oral hygiene behaviors is by using a
colour changing toothpaste. This product is designed to provide visual feedback during
brushing by changing colour to purple after two minutes of brushing. This colour change
helps children to identify that the brushing time is complete. The theory behind a colourchanging toothpaste is that it visually highlights the time needed to complete
toothbrushing. By incorporating a fun, interactive element into the oral hygiene routine,
the colour changing toothpaste could increase children’s engagement, making brushing a
more exciting and rewarding experience.
There is sparse scientific evidence exploring the true effectiveness of this novel
toothpaste to improving children’s brushing technique, motivating them to brush
regularly thereby reducing plaque buildup. While evidence suggests that children may
find such products engaging, there has been little rigorous research to assess their
potential to enhance oral hygiene behaviors systematically. This study aims to fill this gap
by investigating the role of color changing toothpaste in influencing children’s oral
hygiene behaviors, specifically focusing on the following key areas: Improvement in brushing technique, Increased motivation, Long term oral hygiene habits |