| CTRI Number |
CTRI/2019/05/019336 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
23/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Antimicrobial efficacy of White Tea and Green Tea mouthrinse against Dental Plaque, gingivitis and Salivary Streptococcus mutans |
|
Scientific Title of Study
|
Efficacy of White Tea and Green Tea mouthrinse compared to chlorhexidine mouthrinse against dental plaque, gingivitis and Salivary Streptococcus mutans: A Randomized Controlled 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 Shilpa Arora |
| Designation |
MDS Student |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research, Faridabad |
| Address |
Post graduate student, Room no. 3, Department of Public Health Dentistry, Sudha Rustagi College of Dental Sciences and Reasearch, Faridabad, Haryana (121002)
Faridabad
HARYANA
121002
India |
| Phone |
8929124678 |
| Fax |
|
| Email |
drshilpaarora007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C M Marya |
| Designation |
Principal |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Reasearch, Faridabad |
| Address |
Department Number- 3, Public Health Dentistry, Sudha Rustagi College of Dental Sciences and Reasearch, Sector 89, Kheri More, Faridabad, Haryana (121002)
Faridabad
HARYANA
121002
India |
| Phone |
9811144408 |
| Fax |
|
| Email |
maryacm@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Nagpal |
| Designation |
Professor |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research, Faridabad |
| Address |
Department Number- 3, Public Health Dentistry, Sudha Rustagi College of Dental Sciences and Reasearch, Sector 89, Kheri More, Faridabad, Haryana (121002)
Faridabad
HARYANA
121002
India |
| Phone |
9811415169 |
| Fax |
|
| Email |
drruchinagpal1975@gmail.com |
|
|
Source of Monetary or Material Support
|
| self Shilpa Arora, T4-602, RPS SAVANA, Sector-88, Faridabad |
|
|
Primary Sponsor
|
| Name |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Sector 89, Kheri More, Faridabad, Haryana (121002) |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Shilpa Arora |
Sudha Rustagi College of Dental Sciences and Research, Faridabad |
Department Number- 3, Public Health Dentistry, Sudha Rustagi College of Dental Sciences and Reasearch, Sector 89, Kheri More, Faridabad, Haryana (121002)
Faridabad
HARYANA |
8929124678
drshilpaarora007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Sudha Rustagi College of Dental Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
individual who is having gingivitis. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouthwash |
Commercially available formulation of 0.12% CHX was used as positive control. |
| Intervention |
Green Tea mouthwash |
The 1% green tea will be freshly prepared by adding 1 g of the green tea extract to 100 ml of distilled water |
| Intervention |
White Tea mouthwash |
The 1% white tea will be freshly prepared by adding 1 g of the white tea extract to 100 ml of distilled water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Minimum 20 sound, natural teeth (non-carious)
2. Subjects willing to give an informed consent and follow the schedule.
3. Subjects with good general health.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with grossly decayed teeth, full crown or extensively restored teeth or undergoing orthodontic treatment.
2. Subjects with any intraoral soft tissue pathology.
3. Subjects undergoing antibiotic treatment or had it in last one month
4. Subjects using antimicrobial mouthrinses.
5. Subjects consuming a high polyphenol diet (including green tea or soya diet),
6. Subjects wearing appliances, or prostheses (fixed or removable)
7. Subjects with smoking habit.
8. Subjects having history of periodontal treatment within last 3 months.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Loe & Silness Gingival Index
2. Turesky-Gilmore modification of Quigley Hein Plaque Index
3. Salivary Streptococcus mutans (S. mutans) colony count
|
At baseline and at 21 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Staining of teeth – Measured using modified Lobene stain index
2) Taste alteration – Self reported
3) Mucosal irritation – Self reported
|
At baseline and at 21 day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2 |
|
Date of First Enrollment (India)
|
01/06/2019 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: Health benefits of green tea can be attributed to catechins, bio active compounds i.e. polyphenols regarding antioxidant,
anti-cancer , anti-inflammatory, anti-bacterial, anti-mutagenic properties. To our knowledge, very few studies on the beneficial effect of white tea
on oral health are found in literature. Aim: To test the efficacy of white tea and green tea in reducing the plaque index (PI) scores,
gingival index (GI) and Salivary Streptococcus mutans colony count. Methodology: A parallel design randomized controlled trial will be conducted among 66 subjects aged 18-35 years. Participants will be randomized into White Tea, Green Tea and CHX group using lottery method. Subjects will be instructed to use 10 ml of provided mouthwashfor 30 secondstwice daily for 3 weeks. Plaque score, gingival score and Salivary S. mutans colony counts will be recorded at baseline and post-intervention (3 weeks).
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