| CTRI Number |
CTRI/2020/08/027128 [Registered on: 13/08/2020] Trial Registered Prospectively |
| Last Modified On: |
05/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evalution of Triphala Green tea and Chlorhexidine Mouthwashes on Gingivitis |
|
Scientific Title of Study
|
Comparative evaluation of Triphala,Camellia (Green tea) and Chlorhexidine mouthwashes on gingivitis - A Randomized controled clinical trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Rajya Lakshmi |
| Designation |
Post Graduate |
| Affiliation |
Vishnu dental college |
| Address |
Block No 2
Room no 7
Department of Periodontics
Vishnu Dental College
Vishnupur
Bhimavaram
Block No 2
Room no 7
Department of Periodontics
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9441952538 |
| Fax |
|
| Email |
rajimikkili123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gautami s penmetsa |
| Designation |
Head Of the Department |
| Affiliation |
Vishnu dental college |
| Address |
Block No 2
Room no 7
Department of Periodontics
Vishnu Dental College
Vishnupur
Bhimavaram
Block No 2
Room no 7
Department of Periodontics
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Head Of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Block No 2
Room no 7
Department of Periodontics
Vishnu Dental College
Vishnupur
Bhimavaram Block No 2
Room no 7
Department of Periodontics
Vishnu Dental College
Vishnupur
Bhimavaram West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu dental college
Vishnupur
Bhimavaram
West godavari district
534202 |
|
|
Primary Sponsor
|
| Name |
M Rajya lakshmi |
| Address |
Block No 2
Room no 7
Department of Periodontics
Vishnu Dental college
Vishnupur
Bhimavaram
534202 |
| 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 |
| M Rajya Lakshmi |
Vishnu Dental College |
VISHNU DENTAL COLLEGE
VISHNUPUR West Godavari ANDHRA PRADESH |
09441952538
rajimikkili123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vishnu Dental College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy humans suffering with gingivitis |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Camelia mouth wash |
Frequency is twice daily (after braekfast and at bed time
Measure 1/2 ounce (15 milliliters) of the solution using the supplied measuring cup.
Swish the solution in your mouth for 30 seconds, and then spit it out. |
| Comparator Agent |
Chlorhexidine Mouth wash |
Frequency is twice daily (after braekfast and at bed time
Measure 1/2 ounce (15 milliliters) of the solution using the supplied measuring cup.
Swish the solution in your mouth for 30 seconds, and then spit it out. |
| Comparator Agent |
Triphala Mouthwash |
Frequency is twice daily (after braekfast and at bed time
Measure 1/2 ounce (15 milliliters) of the solution using the supplied measuring cup.
Swish the solution in your mouth for 30 seconds, and then spit it out. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with minimum of 20 teeth.
Patients who have not taken periodontal treatment in past 6months
|
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating women
Patients on antibiotic therapy from past 1 month
Smokers
Patients allergic to chlorhexidine, aloevera, triphala.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque Index
Gingival Index
Bleeding Index
|
baseline
15th day
30th day |
|
|
Secondary Outcome
|
|
|
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 1 |
|
Date of First Enrollment (India)
|
17/08/2020 |
| 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="0" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Dental plaque is
associated with the most prevalent oral diseases like dental caries and periodontal
diseases. The removal of plaque is a determining component in the prevention
of these diseases. The use of mechanical agents is a simple and cost
effective method that has been demonstrated to be effective in control of
gingivitis. Most of the individuals do not practice an acceptable standard of
mechanical plaque removal due lack of dexterity in performing oral hygiene
methods.Green tea, Camellia Sinensis from the
family of Thea Cease is mostly cultivated in coasts of Caspian
sea in North of Iran. Its remedial effects are associated with the polyphenol
contents comprising catechin, epicatechin, gallocatechin, epigallocatechin,
epicatechin gallate, and epigallocatechin gallate. Green tea consumption was
found to lower the incidence of cardiovascular disease, diabetes, and obesity.
Green tea is made solely with the leaves of C. sinensis that
have undergone minimal oxidation during processing and hence it has more
antioxidant and antibacterial properties. Studies have shown that green tea
polyphenols inhibit the growth of oral and periodontopathic bacteria thereby
preventing dental caries, halitosis, gingivitis, and periodontitis.
|
The beneficial effects of the natural products along with the lower
prevalence of side effects could enhance patient compliance and long-term
usage. The purpose of the study is to evaluate the efficacy of the green tea in
treatment of gingivitis |