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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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [niharikakubsad@gmail.com].

  6. 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.

  7. 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 . 
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