| 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
|
|
|
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
|
|
|
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 |