| CTRI Number |
CTRI/2025/06/089860 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Dant Kanti Natural Toothpaste in oral health
|
|
Scientific Title of Study
|
Effect of Dant Kanti Natural Toothpaste in Chronic Periodontitis: Prospective, open-label, single-arm, observational 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 |
Dr Kuldeep Singh |
| Designation |
Head Dental Clinic and Research Centre |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 01
First floor Dental Department
Patanjali Ayurveda Hospital Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7060017070 |
| Fax |
|
| Email |
drkuldeep.singh@divyayoga.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kuldeep Singh |
| Designation |
Head Dental Clinic and Research Centre |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 01
First floor Dental Department
Patanjali Ayurveda Hospital Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7060017070 |
| Fax |
|
| Email |
drkuldeep.singh@divyayoga.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kuldeep Singh |
| Designation |
Head Dental Clinic and Research Centre |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 01
First floor Dental Department
Patanjali Ayurveda Hospital Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7060017070 |
| Fax |
|
| Email |
drkuldeep.singh@divyayoga.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Governed by Patanjali Research Foundation Trust NH 58 Near Bahadrabad Haridwar (Uttarakhand) 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation |
| Address |
Patanjali Research Foundation
NH 58 Near Bahadrabad Haridwar (Uttarakhand) 249405 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kuldeep Singh |
Patanjali Ayurveda Hospital |
OPD No 01
First floor Dental Department
Patanjali Ayurveda Hospital Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405
Hardwar
UTTARANCHAL |
07060017070
drkuldeep.singh@divyayoga.com |
| Dr Kuldeep Singh |
Patanjali Wellness |
OPD 70
Dental Department
Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405
Hardwar
UTTARANCHAL |
07060017070
drkuldeep.singh@divyayoga.com |
| Dr Kuldeep Singh |
Patanjali Yoggram |
OPD No 01
Dental Department
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar Uttarakhand India 249402
Hardwar
UTTARANCHAL |
07060017070
drkuldeep.singh@divyayoga.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
At least 20 functional teeth
Good general health
The subject is able and willing to provide consent |
|
| ExclusionCriteria |
| Details |
Systemic antibiotic treatment 30 days before enrolment or during the trial
Individuals with known allergies to any of the ingredients in the toothpaste
Not willing to stop sporadic use less frequently than daily of any other oral
hygiene product dentifrices or oral mouthwash during the study period
Any condition the investigator identifies that can confound the participants ability
to properly participate in the study
Pregnancy or planned pregnancy
The subjects not willing to provide consent
Habit of betel quid chewing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Gingival Index and Plaque Index |
from Day 1 Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the microbial count |
from Day 1 Day 7 and Day 14 |
Changes in the Oral Health Impact
Profile-14 |
from Day 1 Day 7 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
21/07/2025 |
| 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="3"
Months="0"
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 - NO
|
|
Brief Summary
|
This single arm, open label, observational, prospective study will evaluate the effect of Dant Kanti Natural Toothpaste in chronic
periodontitis conditions.
Subjects will be screened based on Inclusion/Exclusion criteria and enrolled after
obtaining written Informed consent. The eligible subjects will be assigned to use Dant
Kanti Natural toothpaste for the next 14 days from the day of enrolment and Gingival Index, Plaque Index, Oral Health Impact
Profile 14 and microbial count will be evaluated. |