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CTRI Number  CTRI/2024/05/067069 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study effect of Ayurvedic Toothpaste in avoiding recurrence of dental calculus after scaling. 
Scientific Title of Study   An Open Labelled Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Dantashodhana Paste After Scaling Treatment In Preventing Recurrence Of Dantasharkara (Dental Calculus) 
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 Sobha Yadav 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  Room No 406 Department of Shalakya Tantra Parul Ayurved Hospital Parul University Limda Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8708180052  
Fax    
Email  sobha290498@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manisha Naringe 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  Room No 406 Department of Shalakya Tantra Parul Ayurved Hospital Parul University Limda Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9726073938  
Fax    
Email  manishanaringe@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manisha Naringe 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  Room No 406 Department of Shalakya Tantra Parul Ayurved Hospital Parul University Limda Vadodara


GUJARAT
391760
India 
Phone  9726073938  
Fax    
Email  manishanaringe@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved, Parul University, Vadodara, Gujarat, 391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Parul University, Vadodara, Gujarat, 391760 
Type of Sponsor  Other [Teaching Hospital of Parul Institute of Ayurved] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sobha Yadav  Parul Ayurved Hospital  OPD No.112, Shalakya Tantra OPD, Parul Ayurved Hospital, Parul University Dr Sobha Yadav PO Limda Tal Waghodia Vadodara 391760
Vadodara
GUJARAT 
8708180052

sobha290498@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Parul Institute of Ayurved,Parul University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K036||Deposits [accretions] on teeth. Ayurveda Condition: Dantasharkara, (2) ICD-10 Condition:K089||Disorder of teeth and supporting structures, unspecified. Ayurveda Condition: DANTASARKARA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-leKana-karma, लेख़न-कर्म (Procedure Reference: SU/CHI 22/36-37,42,CH/SU26/43, Procedure details: Procedure details: The paste should be applied all over the teeth & gingiva with an index finger & then rubbed gently. pressure will be given for 3 to 4 minutes in horizontal, vertical and circular directions.)
(1) Medicine Name: Meswak toothpaste, Reference: Dabur, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 0.25(g), Frequency: bd, Duration: 1 Months
2Intervention ArmProcedure-leKana-karma, लेख़न-कर्म (Procedure Reference: SU/CHI22/36-37,42,CH/SU26/43,, Procedure details: Procedure details: The paste should be applied all over the teeth & gingiva with an index finger & then rubbed gently. pressure will be given for 3 to 4 minutes in horizontal, vertical & circular direction. )
(1) Medicine Name: Madhu laksha paste, Reference: SU/CHI22/36-37,42,CH/SU26/43,, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 0.25(g), Frequency: bd, Duration: 1 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients having Dental Plaque and Supragingival Calculus deposition with any two of the other
symptoms like pain, inflammation, bleeding gums and halitosis will be included for the
present clinical trial.
2 If the patient visits within 5 days after getting the scaling done then he/she will be included
for the present clinical trial.
3 Selection will be irrespective of Gender, Religion & Socio-economic status.
 
 
ExclusionCriteria 
Details  1 Patients having any known case of Cardiac disorders (such as arrythmia, hypertension and
coronary artery disease) and Blood disorders (such as anemia, haemophilia, blood clots and
blood cancer).
2 Patients who require surgical interventions like gingivectomy or gingivoplasty are excluded
from the study.
3 Patients with adverse habits like tobacco and alcohol consumption. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Preventing the recurrence of Dantasharkara (Dental Calculus)  15th day, 30th day and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improves oral health.Reduces the risk of recurrence.  6 months to 1 year. 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/06/2024 
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="6"
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  
Introduction: Ayurveda texts have described the Mukha Roga (diseases affecting the oral cavity) and mentioned the dental diseases under the heading of Danta (teeth) and Dantamula (gum) disease. There are eight types of Danta Rogas (dental disorders) described in the samhithas like Ashtanga and Sushrutha, where Dantasharkara (dental calculus) has been described as one of the Danta Rogas. When gravel like dirt is deposited and fixed on teeth, destroying the normal characteristic of teeth, it is known as Dantasharkara. The symptoms of Dantasharkara and Dental calculus are similar and thus are correlated. As per classics, Dantasharkara, which is explained in Mukharoga under Danta roga diseases, is due to improper oral hygiene by which the vitiated vata dries the kapha and dantamala. As per the symptoms, we can correlate Dantasharkara with Dental Calculus. Dental Calculus is one among the factors in the initiation and progression of a variety of oral diseases. According to the modern science, dental calculus is a hard deposit that forms by the mineralization of dental plaque and is usually covered by a layer of unmineralized plaque. Dental plaque results from colonization and growth of microorganisms on the tooth surface, if not treated in time it may exacerbate the condition leading to gingivitis, periodontal diseases and even tooth loss. Precipitation of the mineral salts into plaque starts between the 1st and the 14th day of plaque formation, and further it leads to Dental calculus over a period of time. In most of the cases plaque deposition leads to calculus formation, gingivitis, periodontitis, and other oral diseases causing gingival recession, bone resorption and finally tooth mobility and loss of tooth.

Aim: To evaluate the efficacy of Dantashodhana paste after scaling in preventing the recurrence of Dantasharkara (Dental Calculus).

Objectives: 1.To study the disease of Dantasharkara in detail according to samhithas. 2. To study the diseases like Dental plaque and Calculus in detail according to the Modern science. 3.To study the effect of Laksha and Madhu paste in the management of Dantasharkara with its properties in detail along with the probable mode of action.

Hypothesis: 
Null hypothesis (H0): Dantashodhana paste is not effective in the management of post scaling procedure in preventing the recurrence of Dantasharkara (Dental calculus). 
Alternate hypothesis (H1): Dantashodhana paste is effective in the management of post scaling procedure in preventing the recurrence of Dantasharkara (Dental calculus).  

Material & Methods : Sources of Data 
1. Literature sources: Literary aspect of the disease Dantasharkara will be studied from Bruhatrayi, laghutarayi, other samhita’s and scientific journals, Published articles and internet sources. Relevant literature of the diseases Dental plaque and Calculus will be studied from Modern texts and various sources related to it. 
 2. Pharmaceutical sources: For conducting the study, purchase of raw material of all ingredients from Parul Ayurveda Pharmacy. Formulation of the drug will be done under the guidance of Parul Ayurveda Pharmacy of Parul Ayurveda Hospital, Parul University, Limda, Waghodia
3. Clinical sources: Patients complaining of symptoms of Dantasharkara, fulfilling the inclusion criteria will be selected irrespective of religion, caste from the O.P.D of Shalakya Tantra Department or referred from other department of Parul Ayurveda Hospital, Limda.Informed consent will be obtained from all the patients before including them in the present study.

Methods of Collection of Data:
Study Design: Type of study- It is an open labelled randomized controlled clinical study between two groups.
Group A (Trial group) - Scaling will be done and followed by Dantashodhana paste along with routine oral hygiene.
Group B (Control group) - Scaling will be done which will be followed by Dabur Meswak Toothpaste along with routine oral hygiene maintenance. 
Study centre: Parul Institute of Ayurveda, Parul Ayurved Hospital.
Sample size: 24 in each group.
Study duration: 60 days.
Methods of Randomization: Computerized randomization.
Consent : Before commencement of study a written informed consent and assent will be taken.Before and after treatment Observation will be done. 
Ethical clearance: The study will be started only after obtaining the clearance from the institutional Ethical committee 

Investigation and test:  BT, CT 
Salivary pH before and after scaling.
Salivary pH before and after applying paste. 

 
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