| CTRI Number |
CTRI/2025/01/079254 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Of Herbal Matcha Extract And 2 percent Chlorhexidine Gluconate On Periodontal Health Status |
|
Scientific Title of Study
|
Comparative Evaluation Of Herbal Matcha Extract And 2 percent Chlorhexidine Gluconate On Periodontal Health Status A Clinico Microbiological 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 Ankita Vinayak Gadekar |
| Designation |
PG Student |
| Affiliation |
JMFs A C P M Dental College Dhule |
| Address |
Department of Public Health Dentistry Room No 8 Third Floor JMFs A C P M Dental College Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
9403483403 |
| Fax |
|
| Email |
gadekarankita2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Vishwakarma |
| Designation |
Professor |
| Affiliation |
JMFs A C P M Dental College |
| Address |
Department of Public Health Dentistry Room No 8 Third Floor JMFs A C P M Dental College Dhule
Sakri Road Dhule 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
9766745627 |
| Fax |
|
| Email |
dr_prashanthvk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Vinayak Gadekar |
| Designation |
PG Student |
| Affiliation |
JMFs A C P M Dental College |
| Address |
Department Of Public Health Dentistry Room No 8 Third Floor A C P M Dental Collge Dhule
Sakri Road Dhule 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
9403483403 |
| Fax |
|
| Email |
gadekarankita2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| JMFs A C P M Dental College Dhule 424001 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Gadekar |
| Address |
A.C.P.M DENTAL COLLEGE, Sakri road Dhule 424001 Maharashtra India |
| 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 Ankita Gadekar |
JMFS ACPM DENTAL COLLEGE, DHULE |
Department of Public Health Dentistry Room No 8 third floor JMFS ACPM DENTAL COLLEGE SAKRI ROAD DHULE
Dhule
MAHARASHTRA
Dhule
MAHARASHTRA |
9403483403
gadekarankita2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JMFs A C P M Dental College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K050||Acute gingivitis. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Camellia sinensis, Reference: Abdul-Wahab HY, Abdulbaqi HR. Does Matcha tea enhance oral health? A narrative review., Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: Powder mix in water | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chlorhexidine Gluconate, Reference: James P, Worthington HV, Parnell C, Harding M, Lamont T, Cheung A, Whelton H, Riley P. Chlorhexidine mouthrinse as an adjunctive treatment for gingival health. Cochrane Database of Systematic Reviews. 2017(3)., Route: Oral, Dosage Form: Dravaka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: Mix 10ml in water |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to participate
Patient with gingivitis and periodontitis
Age group 35 to 55 years |
|
| ExclusionCriteria |
| Details |
Patient with major systemic disease
Subjects with advanced periodontal inflammation or severe malalignment of teeth
Individuals with any allergy or hypersensitivity to herbal medicine |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce gingivitis and periodontitis by reducing plaque accumulation |
Baseline 7 days 14 days and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare two group & check effectiveness |
Baseline 7 days 14 days 28 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title- Comparative Evaluation Of Matcha Extract And 2% Chlorhexidine Gluconate On Periodontal Health Status- A Clinico-microbiological Study Abstract: Introduction: Gingivitis and Periodontitis are a multifactorial inflammatory disease of the oral cavity that results in alveolar bone destruction and is main reason for tooth loss. Matcha tea is a Japanese fine-powdered green tea commonly consumed due to its health-promoting benefits.
Methodology: It is double blinded randomised clinical trial study with 32 adult patient having mild to moderate gingivitis and periodontitis. They were divided into 2 groups each with 16 patients. Group A were given Matcha extract and Group B given 2% Chlorhexidine gluconate. All participants were brought to baseline. They were asked to use their particular group mouthrinse for rinsing twice a day for 1 min. Indices were taken at baseline, 7 days, 14 days and 28 days. MIC (Minimal Inhibitory Concentration) was checked for Matcha extract on both P.gingivalis and S.mutans bacteria. And Gingival crevicular fluid (GCF) were taken at baseline and after 28 days to check Colony forming unit (CFU) of the samples. Results: Matcha mouthrinse significantly reduced inflammatory condition of gingivitis and periodontitis (p<0.05) and is comparable with 2% Chlorhexidine gluconate. In-vitro evaluation of Matcha extract at various concentration of MIC show its effectiveness on P.gingivalis and S.mutans. Conclusion: To conclude Matcha mouthrinse may be recommended as an alternative mouthrinse for improving oral health status.
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