| CTRI Number |
CTRI/2025/08/093396 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
assessment of efficacy of ayurvedic toothpaste in reducing Dentinal hypersensitivity |
|
Scientific Title of Study
|
Assessment of the efficacy of Yashtimadhvadi Pratisarna (Toothpaste) in reducing Dantaharsha (Dentinal Hypersensitivity)-A Clinical and Scanning Electron Microscopic 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 SARIKA PALVE |
| Designation |
Professor and Head Dept of Shalakyatantra Ph.D. Scholar |
| Affiliation |
Bhausaheb Mulak Ayurved College And RH Butibori Nagpur |
| Address |
Department Of Shalakyatantra Bhausaheb Mulak Ayurved College And R.H.Butibori Nagpur
Government Ayurved College Raghuji Nagar Nagpur
Nagpur
MAHARASHTRA
441122
India |
| Phone |
08983421386 |
| Fax |
|
| Email |
dhpsarika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Umale |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Shalakyatantra Government Ayurved College Raghuji Nagar Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
|
| Fax |
|
| Email |
hariumale58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sarika Palve |
| Designation |
Ph.D.S cholar Professor Head Dept of Shalakyatantra ph,D.Scholar |
| Affiliation |
Bhausaheb Mulak Ayurved College And RH Butibori Nagpur |
| Address |
Department of Shalakyatantra Bhausaheb Mulak Ayurved College And Research Hospital Butibori Nagpur
Department of Shalakyatantra Government Ayurved College Raghuji Nagar Nagpur
Nagpur
MAHARASHTRA
441122
India |
| Phone |
08983421386 |
| Fax |
|
| Email |
dhpsarika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College, Nagpur |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College Nagpur |
| Address |
Department of Shalakyatantra, Government Ayurved College, Raghuji Nagar, Nagpur |
| Type of Sponsor |
Government 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 Sarika Palve |
Government Ayurved College Nagpur |
Shalakyatantra OPD Government Ayurved College Raghuji Nagar Nagpur
Nagpur
MAHARASHTRA |
08983421386
dhpsarika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Government Ayurved College Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K038||Other specified diseases of hard tissues of teeth. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Commercially available anti-hypersensitivity toothpaste | Commercially available anti-hypersensitivity toothpaste containing 5% potassium nitrate | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhwadi Pratisaran, Reference: Sushruta, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having dentinal hypersensitivity at least in 2 teeth, having minimum 16 natural teeth free of large restoration or prosthetic crown, at least two teeth showing painful response using dental explorer |
|
| ExclusionCriteria |
| Details |
Teeth with severe caries, faulty restoration, prosthetic crown, chipping, fracture, symptoms of pulpal damage
Participants who has taken long term analgesic therapy within 30 days before the start of the study
Participants who have undergone any treatment for dentinal hypersensitivity in past 3 months
Participants with ongoing orthodontic therapy
Participants with history or presence kidney disorder, kidney stones, eating disorders, uncontrolled gastro-oesophageal reflux disease, excessive exposure to acids or any other systemic condition that predisposes to dentinal hypersensitivity
Severe Periodontal disease characterized by extensive tooth mobility and or extensive alveolar bone loss involving 10 or more teeth
Women who are pregnant or lactating |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in dentinal hypersensitivity (Dantaharsha) as measured by Visual Analog Scale (VAS) scores after application of Yashtimadhwadi Pratisarana.
Evaluation of changes in clinical symptoms (cold, sweet, sour stimuli response) |
At baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of dentinal tubule occlusion through SEM analysis before and after intervention |
Baseline (Day 0) and after completion of intervention (Week 4). |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
20/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Dantaharsha (Dentinal Hypersensitivity) is a common dental complaint characterized by sharp pain in response to thermal, chemical, or tactile stimuli due to exposed dentinal tubules. The present clinical study aims to evaluate the efficacy of Yashtimadhwadi Pratisarana (Ayurvedic toothpaste prepared from Yashtimadhu-based formulation) in reducing dentinal hypersensitivity. Eligible participants will be randomly allocated to receive the intervention for 4 weeks, with assessment of pain reduction using the Visual Analog Scale (VAS) at baseline and post-intervention. The study also includes evaluation of changes in dentinal tubule occlusion through clinical examination (and Scanning Electron Microscopy if applicable). The trial is designed as a single-center, prospective clinical study conducted in the Department of Shalakyatantra, GOVT.AYURVED COLLEGE Nagpur, India. |