| CTRI Number |
CTRI/2025/08/092423 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Dant Kanti Gum Paint on Gingival Bleeding |
|
Scientific Title of Study
|
Effect of Dant Kanti Gum Paint on Gingival Bleeding: 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 Ayurved Hospital Patanjali Yogpeeth Phase 1 |
| 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 |
07060017070 |
| 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 Ayurved Hospital Patanjali Yogpeeth Phase 1 |
| Address |
OPD No 01
First floor Dental Department Patanjali Ayurveda Hospital Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar
UTTARANCHAL
249405
India |
| Phone |
07060017070 |
| 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 Ayurved Hospital Patanjali Yogpeeth Phase 1 |
| Address |
OPD No 01
First floor Dental Department Patanjali Ayurveda Hospital Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar
UTTARANCHAL
249405
India |
| Phone |
07060017070 |
| 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 |
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 Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
7060017070
drkuldeep.singh@divyayoga.com |
| Dr kuldeep Singh |
Patanjali Wellness |
OPD No 70
Dental Department
Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
7060017070
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 249402 Uttarakhand India
Hardwar
UTTARANCHAL |
07060017070
drkuldeep.singh@divyayoga.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Dant Kanti Gum Paint, Reference: NA, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Subjects were instructed to apply a single drop of the gum paint gently by finger or with the help of cotton buds on the gingiva and massage twice daily and to leave it for 5 minutes before rinsing. |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Good general health
Subjects having gingival index more than 1
At baseline all the subjects had to have a plaque index greater than 2 |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases or compromising medical conditions
Patient who made frequent use of painkillers, antiinflammatory and antidepressant drugs
Any condition the investigator identifies that can confound the participants ability to properly participate in the study
Patients who have used mouth rinse containing chemical agents in the previous 2 months
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 the Gingival score Plaque scores Papillary Bleeding Index and Microbial Assessment |
From Day 1 to Day 07 and from Day 01 to Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the Oral Health 15 questionnaire |
From Day 1 to Day 07 and from Day 01 to Day 14 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2025 |
| 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="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 Gum Paint in gingival bleeding. 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 Gum Paint for the next 14 days from the day of enrolment and Gingival score, Plaque scores, papillary bleeding index, microbial assessment will be evaluated to check the efficacy. Oral Health 15 questionnaire will be used to check Oral Health. |