| CTRI Number |
CTRI/2026/04/107542 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Regular Chlorhexidine Mouthwash vs. Chlorhexidine with Natural Bioflavonoids for Better Gum Disease Treatment |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF CHLORHEXIDINE MOUTHWASH WITH AND WITHOUT BIOFLAVONOIDS AS AN ADJUNCT TO NON- SURGICAL PERIODONTAL THERAPY (NSPT): A RANDOMIZED CLINICAL 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 |
DR V VAISHNAVI |
| Designation |
POST GRADUATE STUDENT DEPARTMENT OF PERIODONTICS |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no5 department of periodontics sri hasanamba dental college and hospital
Room no5 department of periodontics sri hasanamba dental college and hospital
Hassan
KARNATAKA
573202
India |
| Phone |
09945565263 |
| Fax |
|
| Email |
drvaishnavi8298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIVEKANANDA M R |
| Designation |
Professor in department of periodontics |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no5 department of periodontics sri hasanamba dental college and hospital
Room no5 department of periodontics sri hasanamba dental college and hospital
Hassan
KARNATAKA
573202
India |
| Phone |
09980843531 |
| Fax |
|
| Email |
vivekcodsperio@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIVEKANANDA M R |
| Designation |
Professor in department of periodontics |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
Room no5 department of periodontics sri hasanamba dental college and hospital
Room no5 department of periodontics sri hasanamba dental college and hospital
Hassan
KARNATAKA
573202
India |
| Phone |
09980843531 |
| Fax |
|
| Email |
vivekcodsperio@ymail.com |
|
|
Source of Monetary or Material Support
|
| Room no5 department of periodontics sri hasanamba dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Sri Hasanamba Dental College and Hospital |
| Address |
Room no5 department of periodontics sri hasanamba dental college and hospital |
| 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 VIVEKANANDA M R |
Sri Hasanamba Dental College and Hospital |
Room no5 department of periodontics sri hasanamba dental college and hospital
Hassan
KARNATAKA |
09980843531
vivekcodsperio@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe (R), Sri Hasanamba Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash |
usage of chlorhexidine mouthwash without bioflavonoids in patients with chronic periodontitis after scaling and rootplaning followed by evaluation of Gingival Index Plaque Index Pocket probing depth Full mouth bleeding score |
| Intervention |
chlorhexidine mouthwash with bioflavonoids |
usage of chlorhexidine mouthwash with bioflavonoids in patients with chronic periodontitis after scaling and rootplaning followed by evaluation of Gingival Index Plaque Index Pocket probing depth Full mouth bleeding score
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Willingness to comply with the study protocol.
2 Participants who were diagnosed with chronic generalized periodontitis.
3 No periodontal therapy rendered within the previous 12 months.
4 Participants with age group of 18 to 45yrs for either sex.
5 Presence of more than 10 natural teeth
6 Non-smokers or light smokers 5 cigarettes per day
7 At least two sites with probing depth greater than 5 mm
|
|
| ExclusionCriteria |
| Details |
1 Participants suffering from any systemic diseases
2 History of head and neck radiotherapy
3 Pregnancy or breastfeeding
4 Known allergy to chlorhexidine and bioflavonoids
5 Participants who had received any antibiotic therapy in past 6months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in gingival inflammation probing pocket depth bleeding on probing and overall plaque formation |
the outcome will be the assessed/estimated at baseline 14 day 30th day & 60th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
08/04/2026 |
| 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="3"
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
|
This randomized clinical trial compares the effectiveness of chlorhexidine mouthwash with and without bioflavonoids when used alongside non-surgical periodontal therapy (NSPT). The study aims to determine whether adding bioflavonoids enhances the therapeutic benefits of chlorhexidine in improving periodontal health which is meassured using gingival index, plaque index,pocket probing depth,bleeding index |