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
|
|
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
|
|
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. |