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CTRI Number  CTRI/2024/08/072013 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Usefulness of Kshara Taila in Plaque-induced Gingivitis 
Scientific Title of Study   Efficacy of Kshara Taila in Plaque induced Gingivitis A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishnu Govind M 
Designation  Assistant professor 
Affiliation  The CVM University 
Address  Department of Shalakyatantra, G J patel Institute of Ayurvedic Studies and Research, New Vallabh Vidyanagar

Anand
GUJARAT
388121
India 
Phone  9497525695  
Fax    
Email  vishnu.madhavan@cvmu.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vimal Panchani 
Designation  Professor and HOD 
Affiliation  The CVM University 
Address  Department of Shalakyatantra, G J patel Institute of Ayurvedic Studies and Research, New Vallabh Vidyanagar

Anand
GUJARAT
388121
India 
Phone  9898381314  
Fax    
Email  vimalben.panchani@cvmu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Vishnu Govind M 
Designation  Assistant professor 
Affiliation  The CVM University 
Address  Department of Shalakyatantra, G J patel Institute of Ayurvedic Studies and Research, New Vallabh Vidyanagar


GUJARAT
388121
India 
Phone  9497525695  
Fax    
Email  vishnu.madhavan@cvmu.edu.in  
 
Source of Monetary or Material Support  
G J Patel Institute of Ayurvedic Studies & Research New VV Nagar Anand 388121 
 
Primary Sponsor  
Name  G J Patel Institute of Ayurvedic Studies & Research 
Address  Department of Shalakyatantra G J Patel Institute of Ayurvedic Studies & Research New VV Nagar Anand 388121 
Type of Sponsor  Private medical college 
 
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 Vishnu Govind M  S G Patel Ayurveda Hospital & maternity Home  Department of Shalakyatantra, OP No. 17
Anand
GUJARAT 
9497525695

vishnu.madhavan@cvmu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CERTIFICATE OF APPROVAL OF INSTITUTIONAL HUMAN ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: DANTASARKARA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kavalaH (Procedure Reference: Ashtanga Hrudaya, Sutrasthana, Chapter 22, Procedure details: 15 ml lukewarm oil is swished around the mouth for 15 minutes. Then rinse the mouth with hot water and brush teeth. Foods or drinks can be had immediately.)
(1) Medicine Name: Kshara Taila, Reference: Ashtanga Hrudaya, Uttarasthana, 18/26-29, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 14 Days
2Comparator Arm (Non Ayurveda)-0.2% chlorhexidine15 mL 0.2% chlorhexidine is swished around the mouth for one minute, after brushing teeth in the morning. Participant must wait 60 minutes before having something to eat or drink. It must be done continuously for 14 days.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) An anticipated ability to attend the scheduled visits
2) Having plaque-induced gingivitis (ICD-10-CM Diagnosis Code K05.10)
 
 
ExclusionCriteria 
Details  1) Participants contra-indicated for gandusha or kavalagraha
2) Less than 20 natural teeth
3) Participants who are pregnant or nursing.
4) A dental student or faculty or dental staff member.
5) Usage of fixed or removable orthodontic appliance
6) Clinical loss of periodontal ligament / attachment
7) Recent history of (within two weeks prior to examination), or ongoing, antibiotic therapy.
8) A need for immediate antimicrobial treatment for periodontitis.
9) Continuing use of anticoagulant medications
10) Dry mouth syndrome or significant food allergies.
11) Any dental procedures or oral prophylaxis within 15 days prior to examination
12) Presence of an intraoral soft tissue pathology
13) Smoking
14) Any significant medical condition that contributes to the development of dental plaque (like diabetes, cardiovascular diseases, autoimmune conditions etc)
15) Presence of major physical or mental limitation or restriction that prohibit the hygiene procedures used in the study protocol
16) Any other condition which in the opinion of the investigators places the participant at risk if they were to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Bleeding on probing score (BOP), expressed in percentage.  8 days after treatment and 16 days after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
1) Modified Gingival Index
2) Modified Plaque Score 
8 days after treatment and 16 days after treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   15/08/2024 
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="0"
Months="8"
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  

Plaque-induced gingivitis is generally regarded as a site-specific inflammatory condition initiated by dental biofilm accumulation and characterized by gingival redness and edema and the absence of periodontal attachment loss. The disease is commonly painless, rarely leads to spontaneous bleeding, and is often characterized by subtle clinical changes detectable only by trained personnels. Consequently, most patients are either unaware of it or unable to recognize it. Recent reports suggest that it is found in 46.6% of the adult Indian population.

The standard treatment of gingivitis is the use of antiseptic mouthwash containing chlorhexidine. Despite its wide use, chlorhexidine is recognised as a corrosive, irritant, health hazard and environmental hazard by the Globally Harmonized System of Classification and Labelling of Chemicals. Chlorhexidine has known common side effects such as increased plaque, peeling of oral mucosa, dry mouth, tongue discolouration, teeth sensitivity, altered taste perception, short bursts of burning sensation, and teeth staining. More recent reviews concluded that the result of kavala / oil-pulling is comparable to that of chlorhexidine, without showing any side effects. But the oils tested in these studies— coconut oil, gingelly oil, olive oil etc.—were randomly chosen based on anecdotes, not based on an existing guideline from any traditional medicines.

The closest correlation of plaque-induced gingivitis in Ayurveda is dantasharkara which is described as a firm accumulation of mala on teeth. Caused by the lack of dental hygiene leading to the shoshana of kapha by vata, dantasharkara deteriorates the normal properties of teeth and presents with halitosis. Since spontaneous bleeding is not specified in this condition, the clinical picture here is that of stage 2 or 3 gingivitis. Dantasharkara is managed by lekhana (scraping) and kshara taila avasechana (oil-pulling). Lekhana karma for dantasharkara has not been standardised yet and the effect of kshara taila oil-pulling in plaque-induced gingivitis remains to be studied. Hence the current study intends to evaluate the efficacy of kshara taila oil-pulling in plaque-induced gingivitis. 
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