| CTRI Number |
CTRI/2024/11/077495 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This Clinical Trial will be performed to understand the effect of prepared ayurvedic medicine Dashmulaadi kwath in dentine hypersensitivity. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical study to evaluate the efficacy of Dashmuladi kwath Kawal and Toothpaste having desensitizing agent in Dentine Hypersensitivity. |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAmbika |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College Of Ayurved And Research center |
| Address |
PDEAS College Of Ayurved And Research Center Third Floor Shalakya Dept sec 25 Pradhikaran Nidhi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9404361342 |
| Fax |
|
| Email |
ambikakattewar07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSandeepDarunde |
| Designation |
Asso professor |
| Affiliation |
PDEAS College of Ayurved And Research Center |
| Address |
PDEAS College of Ayurved And Research CenterShalakya Dept sec25 pradhikaran Nigdi pune
Pune
MAHARASHTRA
411044
India |
| Phone |
0 |
| Fax |
|
| Email |
swd420@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAmbika |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved And Research Center Nigdi |
| Address |
PDEAS College of Ayurved And Research Center third floor shalakyatantra department sector 25 pradhikaran Nigadi
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9404361342 |
| Fax |
|
| Email |
ambikakattewar07@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved And Research Center sector 25 pradhikaran Nigdi pune
Maharashtra
411044
India |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved And Research Center |
| Address |
PDEAS College of Ayurved And Research Center 3rd floor Shalakya yantra department,sec25 pradhikaran Nigdi Pune |
| 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 Ambika |
Ayurved Rugnalaya And Sterling Multispeciality hospital |
Shalakya Department opd no 122,bhel chowk pradhikaran nigdi pune.
Pune
MAHARASHTRA |
9404361342
ambikakattewar07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K088||Other specified disorders of teethand supporting structures. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmuladi kwath, Reference: Chakradatta Chikitsa sthan, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Toothpaste having desensitizing agent (sensodyne toothpaste), Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 0.45(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age group 20 to 60 years irrespective of sex,religion and socioeconomic status.
Incapability of teeth to tolerate breez.
Intolerance to hot,cold,sore food substances.
Patients having Dentine Hypersensitivity due to exposure of Dentine as a result of loss of enamel will be included in present study.
|
|
| ExclusionCriteria |
| Details |
Traumatic conditions of the oral cavity.
Known case of Gingivitis, Gangal recession, tooth mobility and patient requiring surgical modalities such as root canal,pulpectomy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Dentine Hypersensitivity will be evaluated over the period of 5 sdays when given in doe of 40 ml kwath twice a day. |
5 days treatment with follow up on 3rd and 5th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of dental and oral health |
5 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
09/12/2024 |
| 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)
|
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
|
Dantaharsha is one among Dantaroga. Clinically Dantaharsha shows similarities with Dentine Hypersensitivity. Lack of oral hygiene, tooth grinding, habitual ingestion of acidic substances causes erosions of enamel, dentin; those who use smokeless tobacco; those who suffering from gastro oesophageal reflux which increases intraoral acidity and causes erosion of enamel; periodontal disease, gum diseases results in Dentine Hypersensitivity.
Dentine Hypersensitivity is defined as a short, sharp pain arising from exposed dentine in response to thermal, tactile, chemical, evaporative stimulus, which cannot be related to any other dental defect or any other dental pathology. The prevalence of Dentine Hypersensitivity is 4 to 74%) and in India, it is 25%.Dantaharsha is associated with hypersensitivity of teeth to hot, cold water and air, sour food, pain and loosening of teeth. Many remedies are prescribed in modern medicine for the treatment of dentine hypersensitivity, but these methods are quite costly and causing lot of inconvenience to the patients. Hence it is relevant to develop an easy and economic Ayurvedic medical measures. The ingredients of drules are easily available, cheap, easy to prepare, easy to administer.
Dashmuladi Kwath Kawal dharana will be selected for study reference taken from Chakradatta Chikitsasthana . |