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CTRI Number  CTRI/2025/07/091222 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the effect of chlorhexidine, wheatgrass and lemongrass oil mouthwash among patients with chronic gingivitis  
Scientific Title of Study   Comparing the effect of 0.2 percent Chlorhexidine, Wheat Grass and Lemongrass Oil mouthwash on plaque accumulation and gingivitis among patients with chronic 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  DrSneha  
Designation  Post Graduate  
Affiliation  Subbaiah Institute of Dental Sciences 
Address  Department of Public Health Dentistry Room Number-07 Subbaiah Institute of Dental Sciences, NH-13,Purle,Hole Benavalli Post Shimoga KARNATAKA 577222 India

Shimoga
KARNATAKA
577222
India 
Phone  9071674498  
Fax    
Email  drskull0909@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preethi Nagdev  
Designation  Reader  
Affiliation  Subbaiah Institute of Dental Sciences 
Address  Department of Public Health Dentistry Room- number O7 Subbaiah Institute of Dental Sciences, NH-13,Purle,Hole Benavalli Post Shimoga KARNATAKA 577222 India

Shimoga
KARNATAKA
577222
India 
Phone  9964523332  
Fax    
Email  preethinagdev86@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrSneha  
Designation  Post Graduate  
Affiliation  Subbaiah Institute of Dental Sciences 
Address  Department of Public Health Dentistry Room Number O7 Subbaiah Institute of Dental Sciences, NH-13,Purle,Hole Benavalli Post Shimoga KARNATAKA 577222 India

Shimoga
KARNATAKA
577222
India 
Phone  9071674498  
Fax    
Email  drskull0909@gmail.com  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry Room Number-07 Subbaiah Institute of Dental Sciences, NH-13,Purle,Hole Benavalli Post Shimoga KARNATAKA 577222 India  
 
Primary Sponsor  
Name  Subbaiah Institute of dental sciences  
Address  Department of Public Health Dentistry Room Number-07 Subbaiah Institute of Dental Sciences, NH-13,Purle,Hole Benavalli Post Shimoga KARNATAKA 577222 India  
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 Suresh B S   Subbaiah Institute of Dental Sciences  Department of Pediatric and Preventive Dentistry Room Number 05 Subbaiah Institute of Dental Sciences NH 13 Purle Hole Benavalli Post 577222India
Shimoga
KARNATAKA 		 9229991000

principalsubbaiahdental@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee shivamogga   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:Z768||Persons encountering health services in other specified circumstances. Ayurveda Condition: SHE,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: wheatgrass mouthwash and lemon grass oil mouthwash , Reference: wheat grass juice and lemongrass oil, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-chlorhexidine 2% chlorhexidine mouthwash
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 35-65 years
Patients with informed consent
Patients with plaque score 2 and 3 Silness J and Loe H 1964
Patients with gingivitis score 2 and3 Loe H and Silness J 1963
Residents of Shivamogga  
 
ExclusionCriteria 
Details  Patients who have undergone periodontal surgical or non-surgical therapy or used chemotherapeutic mouth rinse or oral irrigation in the past 1 month.
Patients with a history of systemic diseases or conditions 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
reduction in plaque accumulation and chronic gingivitis   At baseline , 14 days, 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   15/08/2025 
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="0"
Days="21" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

 AIM OF THE STUDY:

The aim of the study is to evaluate and compare the effect of the 0.2% chlorhexidine wheat grass and lemon grass oil mouthwashes on plaque accumulation and chronic gingivitis among patients aged 35 65 years

 

OBJECTIVES OF THE STUDY

· To assess the effect of 0.2% Chlorhexidine mouthwash on plaque accumulation and chronic gingivitis using plaque index and gingival index

· To assess the effect of wheat grass mouthwash on plaque accumulation and chronic gingivitis using plaque index and gingival index

· To assess the effect of lemongrass oil mouthwash on plaque accumulation and chronic gingivitis using plaque index and gingival index

· To compare the effect of 0.2% Chlorhexidine, wheat grass and lemongrass oil   mouthwashes on plaque accumulation and chronic gingivitis

Research HypothesisH1  Wheat grass and lemongrass oil mouthwash helps in reducing plaque accumulation and gingivitis among patients with chronic gingivitis

 

Null HypothesisH0 Wheat grass and lemongrass oil mouthwash doesn’t help in reducing plaque accumulation and gingivitis among patients with chronic gingivitis

 


 
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