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CTRI Number  CTRI/2023/06/054467 [Registered on: 27/06/2023] Trial Registered Prospectively
Last Modified On: 26/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of dental calculus through ayurvedic line of management 
Scientific Title of Study   A controlled clinical study to evaluate the effect of kushtadi churna pratisarana after lekhana karma (ultrasonic scaling) in the management of dantasharkara 
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 Jyothi 
Designation  2nd year MS (Ayu) scholar 
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center 
Address  Department of post graduate studies in shalakya tantra Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center

Koppal
KARNATAKA
583231
India 
Phone  7259181444  
Fax    
Email  drjyothipatilsugur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashikala Khadabadi 
Designation  Associate Professor 
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center 
Address  Department of post graduate studies in shalakya tantra Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center

Koppal
KARNATAKA
583231
India 
Phone  8951315404  
Fax    
Email  dr.shashi17@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shashikala Khadabadi 
Designation  Associate Professor 
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center 
Address  Department of post graduate studies in shalakya tantra Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center


KARNATAKA
583231
India 
Phone  8951315404  
Fax    
Email  dr.shashi17@gmail.com  
 
Source of Monetary or Material Support  
Shree jagadguru gavisiddeshwara ayurvedic medical college post graduate studies and research center 
 
Primary Sponsor  
Name  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college Department of Shalakya tantra 
Address  Gavimath campus Koppal 
Type of Sponsor  Research institution and hospital 
 
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 Jyothi  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies and Research Center  Department of Shalakya Tantra Room No 01
Koppal
KARNATAKA 
7259181444

drjyothipatilsugur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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: DANTASARKARA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Scaling and mouthwashscaling- ultrasonic mouthwash - chlorohexadine gluconate 0.2% Route- topical Dosage form - liquid dosage- 5ml Frequency - BD Duration - 15 days
2Intervention ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Sushruta Sushruta Samhita with Dalhana Nibandha Sangraha and Gayadas Nyaya Chandrika Panjika Commentary edited by VaidyaYadavjiTrikamji Acharya, Published by Chaukhamba Sanskrit Sansthan Varanasi. Reprint Edition 2014 Nidana Sthana chapter 16 shloka no 32 Page no 106, Procedure details: Lekhana karma followed by Pratisarana)
(1) Medicine Name: Kushtadi choorna, Reference: 9. Sharangadaracharya Sharangadhara Samhita with English translation by Dr G PrabhakarRao Published by Chaukhamba Publications Varanasi 2016 Gandushakavadi vidhi chapter 10 shloka 18 Page no 305, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with the classical clinical features of Dantasharkara.
Patients with supragingival calculus.
 
 
ExclusionCriteria 
Details  Patients having any communicable disorders, cardiac pacemaker.
Mobile teeth,dental carries and bleeding disorders.
Patients requiring surgical intervention
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to reduce the dental calculus,   60 days 
 
Secondary Outcome  
Outcome  TimePoints 
to reduce halitosis, toothache, inflammation of gums  15 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   10/07/2023 
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="0"
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  

Danta Sharkara is one among the ashtadanta roga1.Dantasharkara is a disease which destroy the dantaguna (qualities of tooth) and Dantashukla (enamel and its supporting structures)2.Dantasharkara occurs due to vitiation of vata-kapha, characterized by hardened accumulation of mala on tooth surface and produces Putigandha (foul smell)3. Treatment ofDantasharkaraincludes Lekhana karma(scaling)followed by pratisarana (local application of the medicine),kavala(gargling),Gandusha(Holding the medicated liquid in the mouth), nasya(nasal medication)4. If not treated leads to Kapalika5(enamel gets eroded and detached from teeth along with an overlying crust of calculus).

Dantasharkara can be correlated to Dental calculus.The prevalence rate of dental calculus is 68%6. Dental calculus consists of mineralized bacterial plaque that forms on the surface of natural teeth and dental prosthesis.There are two types of calculus i.e.,supragingival and subgingival calculus.Supragingival calculus is located coronal to gingival margin and usually it is white or whitish yellow in colour; hard, with a clay-like consistency.Subgingival calculus is located below the crest of the marginal gingiva; it is typically hard and dense; appears to be dark brown or greenish black in colour7.

Treatment of the Dental calculus includes Local therapy (Removal of plaque and topical NSAIDs) and Systemic therapy(Antibiotics and NSAIDs)8.If not treated leads to  periodontal diseases.Prolong usage of NSAIDs and Antibiotics taken orally have substantially and frequent side effects such as upper GI toxicity.

Hence a study to maintain oral hygine and to prevent recurrence of Dantasharkara,lekhana karma(ultrasonic scaling) followed by kustadi churna9 pratisaranais being taken up.

            Kushtadi churna is having lekhana(Scaling) and shodhana property, shleshmapittahara and shothahara action along with antimicrobial and anti-inflammatory action helps in treating and prevention of dantasharkara formation.

Ultrasonic scalingfollowed by Chlor-hexidinegluconate mouth washwill be taken as control.

 
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