| CTRI Number |
CTRI/2020/03/023721 [Registered on: 03/03/2020] Trial Registered Retrospectively |
| Last Modified On: |
03/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Green tea on mutans streptococci |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Green tea and Chlorhexidine mouthrinses in reducing the Streptococcus mutans count in saliva - A Randomized Control 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 Priscilla Joys N |
| Designation |
Post graduate student |
| Affiliation |
Best Dental Science College, Madurai |
| Address |
271, Saradha Mill Road,
Podanur,
Coimbatore.
Department of Public Health Dentistry
Best Dental Science College,
Madurai - 625104
Madurai
TAMIL NADU
641023
India |
| Phone |
9003677047 |
| Fax |
9003677047 |
| Email |
mailpriscy18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muthu Karuppaiah |
| Designation |
Reader and Guide |
| Affiliation |
Best Dental Science College, Madurai |
| Address |
Department of Public Health Dentistry
Best Dental Science College,
Madurai
Madurai
TAMIL NADU
625104
India |
| Phone |
9488614366 |
| Fax |
|
| Email |
drmuthupcd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muthu Karuppaiah R |
| Designation |
Reader and Guide |
| Affiliation |
Best Dental Science College, Madurai |
| Address |
Department of Public Health Dentistry
Best Dental Science College,
Madurai
Madurai
TAMIL NADU
625104
India |
| Phone |
9488614366 |
| Fax |
|
| Email |
drmuthupcd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Priscilla Joys.N MDS
(Self)
271, saradha mill road,
Podanur, coimbatore 641023 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
271, Saradha Mill Road,
Podanur,
Coimbatore |
| 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 Priscilla JoysN |
Senthamil college |
Language lab, ground floor, (Adjacent to Principal office), Poondhotam, Madurai Main, Madurai, Tamil Nadu 625001
Madurai
TAMIL NADU |
9003677047
mailpriscy18@gmail.com |
|
|
Details of Ethics Committee
|
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine |
5 ml of 0.2% Chlorhexidine, orally administered as mouthrinse. One time administration. |
| Intervention |
Green tea extract |
5 ml of 2% green tea mouth rinse, orally administered as mouthrinse. One time administration. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Those with at least one active caries lesion.
2. Those who brush only once daily |
|
| ExclusionCriteria |
| Details |
1.Those Patients who received antibiotic therapy at last 3 weeks,
2.Those who had topical fluoride application at last 48 hours,
3.Those who had topical mouthwash application at last 48 hours and
4.Those who ate or drank within last 2 hours before the study
5.Those with limited manual dexterity.
6.Those with systemic illness/mental illness/physically handicapped
7.Those giving a history of allergy to any of the above constituents of mouthrinses.
8.Those who are pregnant
9.Those who are uncooperative. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mutans streptococci CFU/ml and pH of saliva taken in all the salivary samples |
A salivary sample (sample A) was obtained from the subjects after which a 10% sucrose solution was given. After 7 minutes, Post rinse samples (sample B) were collected in After a waiting period of one hour, a pre rinse saliva (sample C). Following this, 2% Green tea or 0.2% Chlorhexidine rinse was given. After a 20 minute interval, a 10% sucrose solution was given for 2 minutes. After 7 minutes, Post rinse samples (sample B) were collected in the same manner. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2016 |
| Date of Study Completion (India) |
04/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present research is a randomized, parallel arm, controlled trial designed to compare the effect of 2% Green tea extract with 0.2% Chlorhexidine mouthrinse on the Mutans Streptococci count in the saliva and salivary pH. The results could be summarised as: 1. There was a statistically significant reduction in the Mutans Streptococci colonies in the saliva after 0.2% chlorhexidine mouthrinse. 2. There was a statistically significant reduction in the Mutans Streptococci colonies in the saliva after 2% Green tea extract mouthrinse. 3. Significant difference was observed between the Mutans Streptococcus Count (CFU/ml) between the 0.2% Chlorhexidine group and 2% Green tea group. 4. There is a rise in the salivary pH towards neutrality after rinsing with the 0.2% Chlorhexidine mouthrinse but this is not statistically significant. 5. The inhibition of the fall in the salivary pH after 2% Green tea extract mouthrinse is clearly demonstrated and is statistically significant. Thus we can conclude that, 2% Green tea was considerably efficacious in reducing the Mutans Streptococci count significantly, although not superior to the gold standard 0.2% Chlorhexidine. It proves to be a promising anticariogenic mouthrinse with its acid inhibition property in this research by maintaining the salivary pH near neutrality significantly, even after a sucrose challenge and can be used as a cost effective and safe caries inhibitory agent. |