| CTRI Number |
CTRI/2025/03/081684 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dantaraksha Toothpaste in childhood dental caries |
|
Scientific Title of Study
|
Efficacy of dantaraksha toothpaste in comparison to pediflor kidz toothpaste in prevention of krimidanta, early childhood caries- a double blind randomized controlled clinical 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 Kalambe Darshan Dinkar |
| Designation |
Post Graduation Scholar, Department of Kaumarabhritya |
| Affiliation |
SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore |
| Address |
Department of Kaumarabhritya, Opd number 7,8,9 and 23 and dental OPD. SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway Bangalore - 560074 Karnataka, India
Department of Kaumarabhritya, Opd number 7,8,9 and 23 and dental OPD. SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway Bangalore - 560074 Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9860618771 |
| Fax |
|
| Email |
darshankalambe8928@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena K |
| Designation |
Professor and Head, Department of Kaumarabhritya |
| Affiliation |
SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post,Bangalore |
| Address |
Department of Kaumarabhritya, Opd number 7,8,9 and 23 and dental OPD. SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway Bangalore - 560074 Karnataka, India
Department of Kaumarabhritya, Opd number 7,8,9 and 23 and dental OPD. SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway Bangalore - 560074 Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9480478639 |
| Fax |
|
| Email |
drreenakulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalambe Darshan Dinkar |
| Designation |
Post Graduation Scholar, Department of Kaumarabhritya |
| Affiliation |
SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore |
| Address |
Department of Kaumarabhritya, Opd number 7,8,9 and 23 and dental OPD. SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway Bangalore - 560074 Karnataka, India
Department of Kaumarabhritya, Opd number 7,8,9 and 23 and dental OPD. SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway Bangalore - 560074 Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9860618771 |
| Fax |
|
| Email |
darshankalambe8928@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarabhritya, Opd number 7,8,9 and 23 and dental OPD. SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway Bangalore - 560074 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bangalore |
| Address |
Department of Kaumarabhritya, Opd number 7,8,9 and 23 and Dental OPD, SDM Institute of Ayurveda College and Hospital, Anchepalya, Kumbalagodu post, Bangalore-Mysore Highway Bangalore - 560074 Karnataka, India |
| Type of Sponsor |
Private 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 Kalambe Darshan Dinkar |
Shri Dharmasthala Institute of Ayurveda and Hospital, Anchepalya, Chelleghata, Bangalore |
Department of Kaumarabhritya OPD No. 7,8,9,22,23 and Dental OPD
Bangalore
KARNATAKA |
9860618771
darshankalambe8928@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara Institute of Ayurveda And Hospital, Anchepalya, Kumbalgodu Post Mysore Road, Bengaluru-560074, Karnataka, India Phone: 9741562586 email ID: sdmcabh@gmail.com |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K029||Dental caries, unspecified. Ayurveda Condition: KRUMIDANTAKAH, (2) ICD-10 Condition:K029||Dental caries, unspecified. Ayurveda Condition: KRUMIDANTAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Dantadhavan vidhi, Brushing of teeth by rolling method | (Procedure Reference: Classical refrence, Procedure details: Brushing a teeth by rolling method twice a day.)
(1) Medicine Name: Dantaraksha Toothpaste , Reference: Classical, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 1(g), Frequency: bd, Duration: 45 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Pediflor Kidz Toothpaste | Pediflor kidz is a toothpaste in which main ingredient is pediflor and generally used in kids to prevent dental caries |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of age group 3-6 years of either sex presenting with Krimidanta, Dental caries with two or more symptoms mentioned under diagnostic criteria will be included in the study.
2.Parents willing to participate their kid and ready to sign assent/ consent form.
|
|
| ExclusionCriteria |
| Details |
1.Children with advanced periodontal disease.
2.Children using orthodontic appliances.
3.Use of antibiotics for a dental cause in last 1month.
4.Children on mouth rinses for the last 3 months.
5.Children having other diseases of oral cavity.
6. Children allergic to tooth paste.
|
|
|
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 |
| Reduction in clinical features in Krimidanta, dental caries and improvement in oral hygiene |
At baseline, 15th day, 30th day and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identify risk factors for dental caries.
|
45 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
Efficacy of dantaraksha toothpaste in comparison
to pediflor kidz toothpaste in prevention of Krimidanta, early childhood caries
- a double blind randomized controlled clinical trial. In my
study I have taken 2 groups Group 1 is of trail drug Dantaraksha toothpaste and
Group 2 is of control group Pediflor kidz toothpaste. Medicinine will be selected
by computer cheat methods. Here both the participant and investigator will be
blind only guide will know the drug which is selected. Duration of the study is
for 45 days and after 15 days follow up will be their Methodology is Interventional (clinical) For study
group: 3 to 6 years old children with the
manifestation of Krimidanta, Early Childhood caries attending Kaumarabhritya
outpatient department and in patient department of Sri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital (SDMIAH), Bengaluru. For
control group: 3 to 6 years old children with the manifestation of
Krimidanta, Early Childhood Caries attending Kaumarabhritya outpatient
department and in patient department of Sri Dharmasthala Manjunatheshwara
Institute of Ayurveda and Hospital (SDMIAH), Bengaluru. |