CTRI Number |
CTRI/2024/10/075791 [Registered on: 24/10/2024] Trial Registered Prospectively |
Last Modified On: |
23/10/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Use of Bramhi as a mouth rinse for gum disease |
Scientific Title of Study
|
Assessment and Comparison of anti inflammatory activity of Bacopa monnieri mouthwash with chlorhexidene A clinico- biochemical study |
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 Leena Shettar |
Designation |
Professor Department of periodontics |
Affiliation |
SDM College of Dental Sciences Dharwad |
Address |
Professor
Department of Periodontics
SDM college of dental sciences and hospital Sattur
Dharwad
Dharwad KARNATAKA 580009 India |
Phone |
9480218312 |
Fax |
|
Email |
leenagcp@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Leena Shettar |
Designation |
Professor Department of periodontics |
Affiliation |
SDM College of Dental Sciences Dharwad |
Address |
Professor
Department of Periodontics
SDM college of dental sciences and hospital Sattur
Dharwad
Dharwad KARNATAKA 580009 India |
Phone |
9480218312 |
Fax |
|
Email |
leenagcp@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Leena Shettar |
Designation |
Professor Department of periodontics |
Affiliation |
SDM College of Dental Sciences Dharwad |
Address |
Professor
Department of Periodontics
SDM college of dental sciences and hospital Sattur
Dharwad
Dharwad KARNATAKA 580009 India |
Phone |
9480218312 |
Fax |
|
Email |
leenagcp@rediffmail.com |
|
Source of Monetary or Material Support
|
SDM college of dental sciences Dharwad 580009 Karnataka India |
|
Primary Sponsor
|
Name |
Niharika KG |
Address |
SDM college of dental sciences Dharwad |
Type of Sponsor |
Other [self funded] |
|
Details of Secondary Sponsor
|
Name |
Address |
Niharika K G |
SDM college of dental sciences Dharwad |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Niharika K G |
SDM College of dental sciences and hospital |
Department of Periodontics
room no 7 Dharwad KARNATAKA |
6360359896
niharikakubsad@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SDMCDS ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
use of chlorhexidene mouthwash as a control |
use of chlorhexidene mouthwash among gingivitis patients as a positive control for 14 days |
Intervention |
use of mouthwash |
use of bacopa monnieri mouthwash among gingivitis patients after scaling for 14 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
a. Subjects who are systemically healthy
b. Subjects who had moderate to severe gingivitis (Loe and Sillness, 1963)
c. Subjects 18-55years male and females
|
|
ExclusionCriteria |
Details |
a. Subjects who had undergone periodontal treatment for the past 6months
b. Subjects who are already using mouthwash
c. Subjects with gross oral pathology like cysts and tumors
d. Subjects who are on anti biotic and anti-inflammatory medications for past 6 months
e. Smokers and tobacco chewers
f. Pregnant and lactating women
g. subjects allergic to herbal products
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Bacopa monnieri mouthwash can be used as a anti inflammatory mouthwash |
14th day and 21st day |
|
Secondary Outcome
|
Outcome |
TimePoints |
Bacopa monnieri can be used alternative to the routine mouthwashes. |
IL-6 levels at 21st day |
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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 3 |
Date of First Enrollment (India)
|
20/11/2024 |
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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [niharikakubsad@gmail.com].
- For how long will this data be available start date provided 01-02-2024 and end date provided 01-02-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Oral microbiome plays a major role in the initiation of gingival pathology. Dental biofilm comprises of diverse microbial community which are embedded in tooth surfaces as dental plaque. Elimination of plaque has been the hallmark of prevention of the gingival and periodontal infections.Harald Loe and colleagues demonstrated the direct relationship between plaque levels and the development of gingivitis. Plaque removal can reverse the inflammatory changes.Chemical plaque control adjunctive to mechanical plaque control is shown to be more effective. In our study, we aimed to introduce a newer plaque control herbal mouthwash. Herbal medicinehave been applied in dentistry for a long time to inhibit micro organisms, reduce inflammation, soothe irritation, and relieve pain. Bacopa monnieri has been used as a reputed drug in theIndian traditional ayurvedic system for centuries. The medicinal herb with important phytopharmaceuticals has been popularly known as "Brahmi",is a perennial creeping plant found throughout India in wet, damp and marshy areas. In recent years, B. monnieri has been extensively studied for its bioactive constituents,responsible for memory enhancing effect, and its other diverse useful effects as it possesses many pharmacological activities such as antioxidant, anti-inflammatory, gastrointestinal, anti-anxiety, anti-depression, anti-stress, antimicrobial, properties. Bacopa monnieri has been used in medical field in the treatment ofcognitive functions,Alzheimer’s disease, depression, enhance memory development, learning and concentration and to provide relief to patients with anxiety or epileptic disorders. With this background in our present study, we have tried using Bacopa monnieri mouthwash in gingivitis patients. Years of documented research have established chlorhexidine mouthwash is stable, effective in preventing and controlling plaque formation and inhibiting gingivitis. Hence in the current study we are comparing the anti-inflammatory effect of Bacopa monnieri mouthwash with chlorhexidine . |