| CTRI Number |
CTRI/2026/03/106819 [Registered on: 24/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Colour Changing Toothpaste on Brushing Habits and Dental Plaque among School Children |
|
Scientific Title of Study
|
Impact Of Toothpaste With Plaque Disclosing Dye On Oral Hygiene Behaviour And Its Association With Plaque Reduction Among 12 to 15 Years Children At Residential Schools In Shivamogga City A Randomized Controlled 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 |
Dr Arpitha Rao P |
| Designation |
Post Graduate |
| Affiliation |
Subbaiah Institute Of Dental Sciences Shimoga |
| Address |
Room No 07 Department Of Public Health Dentistry Subbaiah Institute Of Dental Sciences Nh 13 Purle Holebenavalli Post Shimoga
Shimoga
KARNATAKA
577222
India |
| Phone |
8310757256 |
| Fax |
|
| Email |
arpitharaop@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek H P |
| Designation |
Professor and Head |
| Affiliation |
Subbaiah Institute Of Dental Sciences Shimioga |
| Address |
Room No 07 Department Of Public Health Dentistry Subbaiah Institute Of Dental Sciences Nh 13 Purle Holebenavalli Post Shimoga
Shimoga
KARNATAKA
577222
India |
| Phone |
8095306448 |
| Fax |
|
| Email |
hpvivek_goku@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ARPITHA RAO P |
| Designation |
POST GRADUATE |
| Affiliation |
Subbaiah Institute Of Dental Sciences Shimoga |
| Address |
Room no 07 Department of Public Health Dentistry Subbaiah Institute of Dental Sciences NH 13 Purle Holebenavalli Post Shimoga
KARNATAKA
577222
India |
| Phone |
8310757256 |
| Fax |
|
| Email |
arpitharaop@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Subbaiah Institute of Dental Sciences Shimoga |
| Address |
Room no 07 Department Of Public Health Dentistry Subbaiah Institute of Dental Sciences NH 13 Purle Holebenavalli Road Shimoga |
| Type of Sponsor |
Other [Private Dental college] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr GIRISH |
Ananya English Medium School |
Mathrushree Vidyavardhaka trust Ashoknagara Shivamogga 577205
Shimoga
KARNATAKA |
9844538325
ananyaresidentialschool24@gmail.com |
| Mr Gopalakrishna |
VIKASA SCHOOL |
VIKASA VIDYA SAMITHI ALKOLA SHIVAMOGGA 577204
Shimoga
KARNATAKA |
8762000097
vikasavidyasamithi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SHIMOGA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants aged 12 to 15 years children should be residing at residential high school Shivamogga city |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TOOTHPASTE WITH PLAQUE DISCLOSING DYE |
calcium carbonate abrasive glycerin humectant sodium lauryl sulphate surfactant gum acacia binder food graded disclosing agent preservatives and flavouring agents for 45 days |
| Comparator Agent |
TOOTHPASTE WITHOUT PLAQUE DISCLOSING DYE |
calcium carbonate abrasive glycerin humectant sodium lauryl sulphate surfactant gum acacia binder food graded disclosing agent preservatives and flavouring agents for 45 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are willing to participate in the study
Parents Guardians who are willing to give consent
Participants aged 12 to 15 years children should be residing at residential high school Shivamogga city
|
|
| ExclusionCriteria |
| Details |
Participants who are not willing to take part in the study
Parents Guardians who are not willing to give consent
Participants with mentally and physically challenged disabilities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CHANGE IN ORAL HYGIENE BEHAVIOUR using OHIS |
BASELINE AFTER 3 MONTHS OF INTERVENTION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/02/2027 |
| 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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM OF THE STUDY: To evaluate the impact of toothpaste with plaque disclosing dye on oral hygiene behavior among 12-15years children at residential schools in Shivamogga city. OBJECTIVES OF THE STUDY: · To assess the plaque accumulation after using toothpaste with plaque disclosing dye for 5 weeks among 12-15 years children at residential school in Shivamogga city using Distal Mesial Plaque Index Fischman & Cancro 1986 · To assess the plaque accumulation after using toothpaste without plaque disclosing dye for 5 weeks among 12-15 years children at residential school in Shivamogga city using Distal Mesial Plaque Index Fischman & Cancro 1986 · To compare plaque accumulation after using toothpaste with and without plaque disclosing dye for 5 weeks among 12-15 years children at residential school in Shivamogga city using Distal Mesial plaque index Fischman & Cancro 1986 · To evaluate the association between toothpaste with plaque disclosing dye and toothpaste without plaque disclosing dye on oral hygiene behavior among 12-15 years children at residential school in Shivamogga city using Oral Hygiene Index-Simplified Greene and Vermillion 1964 Research Hypothesis(H1) There is a difference in oral hygiene behavior between using toothpaste with plaque disclosing dye and toothpaste without plaque disclosing dye among 12-15 years children at residential schools in Shivamogga city Null Hypothesis(H0) There is no difference in oral hygiene behavior between using toothpaste with plaque disclosing dye and toothpaste without plaque disclosing dye among 12-15 years children at residential schools in Shivamogga city
|