| CTRI Number |
CTRI/2025/07/090563 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| 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 Gandush Oil Pulling in Improving Oral Hygiene |
|
Scientific Title of Study
|
Effectiveness of Dant Kanti Gandush Oil Pulling in Improving Oral Hygiene: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 |
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 |
7060017070
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 |
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 Uttarakhand India 249402
Hardwar
UTTARANCHAL |
7060017070
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:K055||Other periodontal diseases. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Dant Kanti Gandush Oil Pulling, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with mild caries risk DMFT score 1 to 2 ( Decayed missing due to caries and Filled Teeth)
Subjects with no history of antibiotic administration for the last 2 weeks
Subjects with no antimicrobial mouth rinse for the last 12 hours
Subjects with no systemic diseases
Subjects willing to give their swab samples for analysis
Able to provide written informed consent
Able and willing to comply with the protocol including availability for all scheduled study visits
|
|
| ExclusionCriteria |
| Details |
Patient allergic to any of the ingredients of medicated oil (test product).
Any history of periodontal therapy by surgical interventions
Subjects with the history of antibiotic use in the past 1 month
Tooth with developmental anomalies and fluorosis
Pregnant or breastfeeding women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in oral microflora: Total bacterial count and differential bacterial count |
Baseline (Day 01), Day 07 & Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in gingival index and plaque index |
Baseline (Day 01), Day 07 & Day 14 |
| Reduction in Organoleptic scale |
Baseline (Day 01), Day 07 & Day 14 |
| Improvement in quality of life by using EORTC QOL-OH15 |
Baseline (Day 01), Day 07 & Day 14 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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 Gandush Oil Pulling in oral health. 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 Gandush Oil Pulling for the next 14 days from the day of enrolment and Gingival score, Plaque scores, organoleptic score, microbial assessment will be evaluated to check the efficacy. Oral Health 15 questionnaire will be used to check oral health.
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