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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K036||Deposits [accretions] on teeth. Ayurveda Condition: DANTASARKARA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm (Non Ayurveda) | | - | Scaling and mouthwash | scaling- ultrasonic
mouthwash - chlorohexadine gluconate 0.2%
Route- topical
Dosage form - liquid
dosage- 5ml
Frequency - BD
Duration - 15 days
| 2 | Intervention Arm | Procedure | - | pratisAraNam, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¤®à¥ | (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. |