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CTRI Number  CTRI/2026/01/102131 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 24/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Two Mouthwashes on Gum Health and Tooth Staining 
Scientific Title of Study   A Comparative Study of the Effect of Chlorhexidine Mouthwash with and without Anti-Discoloration system and Hyaluronic acid on gingivitis and stains 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rakshitha S 
Designation  Post graduate  
Affiliation  JSS Dental college and Hospital 
Address  Dept of Periodontology room no 9 JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore
Dept of Periodontology room no 9 JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore
Mysore
KARNATAKA
570015
India 
Phone  09880355071  
Fax    
Email  rakshitha074@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratibha Shashikumar  
Designation  Reader 
Affiliation  JSS Dental college and Hospital 
Address  Dept of Periodontology room no 9 JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore

Mysore
KARNATAKA
570015
India 
Phone  9986544409  
Fax    
Email  drpratibhavg@gmial.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivananda S 
Designation  Reader 
Affiliation  JSS Dental college and Hospital  
Address  Dept of Oral and maxillofacial surgery room no 6 JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore

Mysore
KARNATAKA
570015
India 
Phone  9343322433  
Fax    
Email  dr.shivanandas@jssuni.edu.in  
 
Source of Monetary or Material Support  
JSS Dental College and Hospital Bangalore Mysore highway Bannimantap Mysore Karnataka 570015  
 
Primary Sponsor  
Name  JSS Dental college and Hospital 
Address  JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore 571440  
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 
Rakshitha S  JSS Dental College and Hospital   Department of Periodontology Room no 9 JSS Dental college and Hospital Banglore Mysore highway Bannimantap Mysore 570015
Mysore
KARNATAKA 
09880355071

rakshitha074@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Dental college and Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gingivitis 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine Mouthwash  Control group Only Chlorhexidine mouthwash without ADS and hyaluronic acid for two months 
Intervention  Chlorhexidine Mouthwash with Anti-Discoloration System and hyaluronic acid   Test group Chlorhexidine with ADS and hyaluronic acid mouthwash for two months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Systemically healthy patients both males and females aged 20-50 yrs presenting with gingivitis

Subjects who had not received periodontal therapy for the past 3 months

Patients who are not smokers

Patients who are cooperative and able to come for regular follow up 
 
ExclusionCriteria 
Details  Patients who are not willing to give consent

Pregnant and lactating women

Subjects with less than 20 permanent teeth remaining

Patients using any other supplemental plaque control measures like interdental cleansing aids or mouthwashes

Patients who had received either antibiotic or anti inflammatory therapy within three months of baseline examination 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Gingival index and Stain index   Baseline and 2 months  
 
Secondary Outcome  
Outcome  TimePoints 
Plaque Index   Baseline and two months  
 
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 2/ Phase 3 
Date of First Enrollment (India)   20/02/2026 
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 Yet Recruiting 
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  

Gingivitis is a reversible inflammatory condition caused by the accumulation of dental biofilm and is characterized by redness swelling and bleeding of the gingiva without loss of periodontal attachment If left untreated it may progress to periodontitis an irreversible condition involving connective tissue destruction loss of periodontal ligament alveolar bone resorption and eventual tooth loss Hence preventing the progression of gingivitis is crucial

Mechanical plaque control remains the gold standard however it requires high patient motivation and manual dexterity Chemical plaque control agents particularly mouthwashes act as useful adjuncts by disrupting biofilm metabolism and reaching areas inaccessible to brushing Chlorhexidine CHX is considered the most effective antiplaque agent due to its strong antimicrobial and anti gingivitis properties though tooth staining is a common side effect To overcome this limitation CHX formulations with an anti discoloration system ADS have been introduced

Hyaluronic acid HA a naturally occurring polysaccharide in periodontal tissues exhibits anti inflammatory bacteriostatic and wound healing properties Its adjunctive use in periodontal therapy has shown promise in reducing gingival inflammation and promoting tissue healing

 
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