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CTRI Number  CTRI/2019/06/019889 [Registered on: 27/06/2019] Trial Registered Prospectively
Last Modified On: 27/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the efficacy of jamun mouthwash on gum diseases and its comparison with chlorexidine mouthwash 
Scientific Title of Study   Comparative evaluation of the efficacy of 5% Indian Jamun Extract and 0.2% Chlorhexidine Gluconate Mouthwash in Prevention of Plaque and Gingivitis among young adults: An In vivo In-vitro Randomized Clinical Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karina S Chachlani 
Designation  2nd year post graduate student 
Affiliation  A.C.P.M Dental College 
Address  Department of Public Health Dentistry, A.C.P.M Dental College, Dhule.

Dhule
MAHARASHTRA
424001
India 
Phone  9763076900  
Fax    
Email  karinachachlani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Dodamani 
Designation  Professor and HOD 
Affiliation  A.C.P.M Dental College 
Address  Department of Public Health Dentistry, A.C.P.M Dental College, Dhule.

Dhule
MAHARASHTRA
424001
India 
Phone  7020669099  
Fax    
Email  drarundodamani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karina S Chachlani 
Designation  2nd year post graduate student 
Affiliation  A.C.P.M Dental College 
Address  Department of Public Health Dentistry, A.C.P.M Dental College, Dhule.


MAHARASHTRA
424001
India 
Phone  9763076900  
Fax    
Email  karinachachlani@gmail.com  
 
Source of Monetary or Material Support  
A.C.P.M Dental College, Dhule 
 
Primary Sponsor  
Name  Dr Karina Chachlani 
Address  A.C.P.M Dental College, Dhule 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karina Chachlani  A.C.P.M Dental College, Dhule  Department of Public Health Dentistry, A.C.P.M Dental College, Dhule.
Dhule
MAHARASHTRA 
9763076900

karinachachlani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
A.C.P.M Medical Ethical and Research Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mild to moderate gingivitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  5 % Jamun mouthwash  to be used twice daily, 15 ml each time, rinsing orally for 30 seconds for a period of 21 days 
Intervention  5 % jamun mouthwash  to be used twice daily, 15ml each time, rinsing orally for 30 seconds for a period of 21 days 
Comparator Agent  commercially available 0.2% chlorhexidine gluconate mouthwash  to be used twice daily, 15 ml each time, rinsing orally for 30 seconds for a period of 21 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Subjects in age group of 18 to 30 years.
2. Subjects following routine oral hygiene procedures.
3. Subjects with mild to moderate gingivitis.
4.Subjects willing to participate in the present study.  
 
ExclusionCriteria 
Details  1.Subjects suffering from systemic diseases.
2.Subjects undergoing orthodontic treatments.
3.Subjects using other aids for oral hygiene apart from toothbrush.
4.Subjects having adverse habits like smoking, alcohol drinking.
5.Subjects not willing to participate in the present study.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare in-vivo and in-vitro efficacy of 5% Indian Jamun extract..in vitro testing will be done on agar plates with 3 organisms (Streptococcus mitis porphyromonas gingivalis, tanerella forsythia) and in vivo testing will be done by taking plaque and gingival bleeding index at baseline, 7th day, 14th day and 21st day
mouthwash with 0.2% Chlorhexidine gluconate mouthwash on plaque accumulation and gingivitis among young adults at baseline, 7th, 14th and 21st day.
 
7th, 14th and 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy of mouthwash containing 5% Indian Jamun extract on gingivitis
and plaque accumulation and it’s comparison with 0.2% chlorhexidine gluconate mouthwash among young adults at baseline, 7th, 14th and 21st day (in vivo) using plaque index and gingival bleeding index
2.To evaluate the antimicrobial efficacy of mouthwash containing 5% Indian Jamun extract
against Streptococcus mitis, Porphyromonas gingivalis and Tanerella Forsythia (in vitro) on agar plates 
7th, 14th and 21st day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   18/07/2019 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Periodontal diseases are chronic inflammatory conditions characterized by loss of connective tissue, alveolar bone resorption and formation of periodontal pockets as a result of the complex interaction between pathogenic bacteria and the host′s immune response. Periodontitis starts with inflammatory lesions of the gingiva, which, if left untreated, may progress and eventually involve and compromise the entire periodontal apparatus of the affected teeth. Dental plaque is the primary etiologic factor in periodontal disease.The results of the clinical trials and analysis of literature indicates a strong correlation between microbial plaque levels and severity of gingivitis. Plaque control has long been considered as the cornerstone of its management.
Mechanical hygiene procedures such as tooth brushing, interdental brushing, and dental floss are the key methods of plaque control. However, despite the potential for adequate mechanical plaque control, clinical experience and population-based studies demonstrate that such methods are not being employed sufficiently by large numbers of the population.
Chemical methods of reducing plaque, such as mouthwashes, are less technically demanding alternatives to mechanical plaque control. Chlorhexidine gluconate is the most popular mouthwash which has been recognized by the pharmaceutical industry as the positive control against which the efficacy of alternative antiplaque agents should be measured, and has earned its epitome of gold standard. But its long-term usage may result in various side effects. An effective substitute to chlorhexidine gluconate with all the good qualities and its unpleasant effects is highly desirable and has been long awaited.
From the earliest times, Plants have been exploited by humans for many centuries as sources of medicinal drugs, due to the presence of various bioactive compounds. Plants have not only provided food, cosmetics and embalming ointments, but also a plethora of easily available remedies for the maladies of humanity3. As the popularity of these herbal products continues to rise, dental professionals are expected to provide information to patients about these products safety and efficacy. So herbal mouthwash may act as a good and cost-effective oral hygiene product.
Eugenia jambolana Lam., commonly known as black plum or “jamun” is an important medicinal plant in various traditional systems of medicine. It is effective in the treatment of diabetes mellitus, inflammation, ulcers and diarrhoea and preclinical studies have also shown it to possess chemopreventive, radioprotective, antineoplastic, antiviral, antibacterial and antioxidant properties but most important of all is antidiabetic property . The plant is rich in compounds containing anthocyanins, glucoside, ellagic acid, isoquercetin, kaemferol and myrecetin(4). The seeds are claimed to contain alkaloid, jambosine, and glycoside jambolin or antimellin, which halts the diastatic conversion of starch into sugar. The plant is however less explored for dental use .
Therefore, the present study is conducted to Compare the efficacy of 5% Indian Jamun extract mouthwash with 0.2% Chlorhexidine gluconate mouthwash against plaque accumulation and gingivitis among young adults.

Primary hypothesis: There is no difference between the efficacy of 5% Indian Jamun extract mouthwash and 0.2% Chlorhexidine gluconate mouthwash on plaque accumulation and gingivitis.

Other hyposthesis 1: 5% Indian Jamun extract mouthwash is less effective than 0.2% Chlorhexidine gluconate mouthwash in prevention of plaque accumulation and gingivitis. 

Other hypothesis 2: 5% Indian Jamun extract mouthwash is as good as 0.2% Chlorhexidine gluconate mouthwash in prevention of plaque accumulation and gingivitis. 
 
 
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