| CTRI Number |
CTRI/2025/11/097847 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Dentistry
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical and anti-inflammatory effects of Berberine HCl mouthwash in patients with plaque-induced gingivitis. |
|
Scientific Title of Study
|
Evaluation of Clinical and Anti-Inflammatory efficacy of
Berberine HCI Containing Mouth wash on Dental Plaque
Induced Gingivitis |
| 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 Bhaskarya Bhaskar Bora |
| Designation |
MDS |
| Affiliation |
AB Shetty Dental College |
| Address |
Department of Periodontology, room no. 8, 4th floor .AB Shetty Dental College, Derlakatte, Mangaluru, 575018
Department of Periodontology, room no. 8, 4th floor .AB Shetty Dental College, Derlakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6003966917 |
| Fax |
|
| Email |
bhaskaryab.bora123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr Rahul Bhandary |
| Designation |
Professor |
| Affiliation |
AB Shetty Dental College |
| Address |
AB Shetty Dental College, Derlakatte, Mangaluru, 575018
AB Shetty Dental College, Derlakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845583085 |
| Fax |
|
| Email |
drrahulbhandary@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhaskarya Bhaskar Bora |
| Designation |
MDS |
| Affiliation |
AB Shetty Dental College |
| Address |
AB Shetty Dental College, Derlakatte, Mangaluru, 575018
AB Shetty Dental College, Derlakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6003966917 |
| Fax |
|
| Email |
bhaskaryab.bora123@gmail.com |
|
|
Source of Monetary or Material Support
|
| AB Shetty Dental College, Derlakatte, Mangaluru, 575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Bhaskarya Bhaskar Bora |
A B Shetty memorial institute of dental sciences |
NITTE ( Deemed to be university), Department of Periodontology, 4th floor, Derlakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA |
6003966917
bhaskaryab.bora123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABSMIDS institutional ethicalal committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash |
Patients will be advised to rinse for at least 1 min with 10 mL of chlorhexidine mouthwash twice daily
in the interval of 12 h for 15 days and will be advised not to rinse their mouth for half an hour. |
| Intervention |
Berberine HCl containing mouthwash |
Patients will be advised to rinse for at least 1 min with 10 mL of berberine mouthwash twice daily in the interval of 12 h for 15 days and instruction will be given to not rinse their mouth for half an hour. |
| Comparator Agent |
saline mouth rinse |
Patients will be advised to rinse for at least 1 min with 10mL of 0.9% saline mouth rinse twice daily in the interval of 12 h for 15 days and will be advised not to rinse their mouth for half an hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. 18-40 years of age
2. Patients with moderate to severe gingivitis with a minimum of 20 permanent with gingival inflammation.
3. No previous history of periodontal surgery or consumption of antibiotics/anti-inflammatory medications in the past 6 months.
4. Systemically healthy. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from systemic diseases, which may have an impact on the periodontium, such as
diabetes mellitus and osteoporosis.
2. Uncooperative patients.
3. Patients on antibiotics and/or anti-inflammatory drugs.
4. Patients with a history of drug allergy or hypersensitivity reactions.
5. Smokers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Berberine HCl containing mouthwash has a significant anti-inflammatory and anti-plaque effect on the clinical
signs and biochemical levels of dental plaque-induced gingival inflammation. |
Baseline, day 7, day 15, day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
02/12/2025 |
| 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="1"
Months="0"
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
|
The study titled “Evaluation of Clinical and Anti-Inflammatory Efficacy of Berberine HCl Containing Mouthwash on Plaque-Induced Gingivitis” aims to assess the potential of Berberine HCl mouthwash as a natural alternative to chlorhexidine in managing plaque-induced gingivitis. Ninety-three patients with gingivitis will be divided into three groups using Berberine HCl mouthwash, 0.2% chlorhexidine, or saline rinse for 15 days. Clinical parameters—Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS)—and salivary levels of interleukin-4 (IL-4) and interleukin-6 (IL-6) will be evaluated at baseline, day 15, and day 21. Statistical analysis will compare the anti-plaque and anti-inflammatory effects among the groups. The study is expected to demonstrate that Berberine mouthwash offers comparable or superior clinical and biochemical benefits to chlorhexidine, making it an effective, herbal, and side effect–free alternative for gingivitis management. |