| CTRI Number |
CTRI/2025/07/091937 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the effect of Trikatu toothpaste on caries in fluoridated and non-fluoridated community among 12-15yrs school going children in Shivamogga district |
|
Scientific Title of Study
|
Evaluating the effect of Trikatu as anti-cariogenic toothpaste in fluoridated and non-fluoridated community among 12-15yrs school going children in Shivamogga district-A Double Blinded Randomized Control Trail |
| 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 Prithvik R |
| Designation |
Post Graduate |
| Affiliation |
Subbaiah Institute of Dental sciences |
| Address |
Room no 7, Department of Public Health Dentistry, Subbaiah Institute of Dental sciences, NH-13, Purle, Hole Benavalli Post
Shimoga
KARNATAKA
577222
India |
| Phone |
9110444854 |
| Fax |
|
| Email |
prithvik.r99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIVEK HP |
| Designation |
Professor and Head |
| Affiliation |
Subbaiah Institute of Dental sciences |
| Address |
Room no 7, Department of Public Health dentistry Subbaiah Institute of Dental sciences, NH-13, Purle, Hole Benavalli Post
Shimoga
KARNATAKA
577222
India |
| Phone |
8095306448 |
| Fax |
|
| Email |
hpvivek_goku@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prithvik R |
| Designation |
Post Graduate |
| Affiliation |
Subbaiah Institute of Dental sciences |
| Address |
Room no 7, Department of Public Health Dentistry Subbaiah Institute of Dental sciences, NH-13, Purle, Hole Benavalli Post
Shimoga
KARNATAKA
577222
India |
| Phone |
9110444854 |
| Fax |
|
| Email |
prithvik.r99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subbaiah Institute of Dental Sciences, NH 13 Purle, Shivamogga, Karnataka, India-577222 |
|
|
Primary Sponsor
|
| Name |
Subbaiah institute of dental sciences |
| Address |
NH 13 Purle Shivamogga, Karnataka, India - 577222
|
| Type of Sponsor |
Private medical 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 |
| Dr Preethi Nagdev |
Government High School Gadikoppa |
Gadikoppa, Shimoga Taluk, Shimoga district, Karnataka, India-577205
Shimoga
KARNATAKA |
9964523332
preethinagdev86@gmail.com |
| Dr Vivek HP |
Karnataka Public School GHS Konanduru |
Konandur, Thirthahalli Taluk, Shimoga District, Karnataka, India- 577422
Shimoga
KARNATAKA |
8095306448
hpvivek_goku@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Subbaiah Institute of Dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY CHILDREN |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikatu Toothpaste, Reference: Trikatu churna, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Colgate Strong Teeth | fluoridated toothpaste 3g daily morning and night for 1 year |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Students who are willing to participate
Should should be permanent residents of Fluoridated and non-fluoridated communities in shivamogga city
Students studying in 8th and 9th standard at government high school
students with DMFT/DMFS score more than 1 |
|
| ExclusionCriteria |
| Details |
patient who are not willing to give consent
Students having any underlying systemic diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Status of Decayed, Missing and filled teeth using DMFT index |
at Baseline, 6 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/08/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
AIM OF THE STUDY Evaluating the effect of Trikatu toothpaste as anti-cariogenic toothpaste in fluoridated & non-fluoridated community among 12-15 years school going children in Shivamogga district. OBJECTIVES OF THE STUDY To Evaluate the anti-cariogenic property of Trikatu toothpaste on dental caries in 12- 15 years school going children in fluoridated and non-fluoridated community by using DMFT/DMFS Index by Henry T Klein, Carrole E. Palmer and Knutson – Modified WHO 1997. To Evaluate the anti-cariogenic property of Fluoridated toothpaste on dental caries in 12- 15 years school going children in fluoridated and non-fluoridated community by using DMFT/DMFS Index by Henry T Klein, Carrole E. Palmer and Knutson – Modified WHO 1997. To Compare anti-cariogenic property between Trikatu toothpaste and Fluoridated toothpaste. Research Hypothesis There is an effect of Trikatu as an anti-cariogenic toothpaste in preventing dental caries among 12-15 years school going children in fluoridated and non-fluoridated communities in Shivamogga District. Null Hypothesis There is no effect of Trikatu as an anti-cariogenic toothpaste in preventing dental caries among 12-15 years school going children in fluoridated and non-fluoridated communities in Shivamogga District. |