| CTRI Number |
CTRI/2018/11/016244 [Registered on: 01/11/2018] Trial Registered Prospectively |
| Last Modified On: |
31/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of Red Ginseng mouthwash against dental tartar and gum bleeding |
|
Scientific Title of Study
|
Comparative Assessment of the action of a commercially available Panax ginseng extract containing mouthwash with that of a Chlorhexidine and Sodium Fluoride containing mouthwash against dental Plaque and Gingival bleeding - 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 |
H CYRIL BENEDICT |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL, CHENNAI |
| Address |
No-3, Dulukkanam Street, Village High Road, Sholinganallur, Chennai 600119
Chennai TAMIL NADU 600119 India |
| Phone |
9962365831 |
| Fax |
|
| Email |
cyrilbene@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M B Aswath Narayanan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Tamil NAdu Government Dental College and Hospital, Chennai |
| Address |
Room No 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College and Hospital, No-2, Frazer Bridge Road, Parktown Chennai Room No 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College and Hospital, No-2, Frazer Bridge Road, Parktown Chennai Chennai TAMIL NADU 600003 India |
| Phone |
9840127997 |
| Fax |
|
| Email |
mban1965@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
H CYRIL BENEDICT |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL, CHENNAI |
| Address |
No-3, Dulukkanam Street, Village High Road, Sholinganallur, Chennai 600119
Chennai TAMIL NADU 600119 India |
| Phone |
9962365831 |
| Fax |
|
| Email |
cyrilbene@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self |
| Address |
No 3, dulukkanam street, village high road, sholinganallur, chennai 600119 |
| 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 |
| H Cyril Benedict |
Tamil Nadu Government Dental College and Hospital, chennai |
room no 4, department of Public health dentistry, Tamil NAdu government Dental College and hospital, No 2, Frazer Bridge Road, Parktown, Chennai Chennai TAMIL NADU |
9962365831
cyrilbene@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL - INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine 0.2% mouth rinse |
The product contains Chlorhexidine gluconate in the amount of 0.2% . the patiets are advised to rinse and spit out 10ml of the mouth rinse twice a day |
| Intervention |
Panax ginseng extract containing mouth rinse |
the product contains red ginseng extract in the amount of 0.010 w/w%. the patiets are advised to rinse and spit out 10ml of the mouth rinse twice a day. |
| Comparator Agent |
sodium fluoride mouth rinse |
The product contains sodium fluoride in the amount of 0.2%. the patients are advised to rinse and spit out 10ml of the mouth rinse twice a day |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
subjects with completely erupted permanent dentition |
|
| ExclusionCriteria |
| Details |
subjects with advanced oral diseases
subjects with history of systemic diseases
subjects with history of antibiotic usage in the last one month
subjects with history of tobacco use
subjects with history of alcohol intake
subjects wearing fixed or removable orthodontic or prosthodontic appliances
subjects with known history of hypersensitivity to red ginseng extract pr chlorhexidine or sodium fluoride
subjects who are physically and mentally challenged
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque Index by Silness and Loe 1964
Gingival Index by Loe and Silness 1963 |
the index scores will be obtained from the patients at the time of recruitment(baseline), at 2 weeks m at 4 weeks and at 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| subjective reduction in the bleeding of gums |
the index scores will be obtained from the patients at the time of recruitment(baseline), at 2 weeks m at 4 weeks and at 6th week |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
05/11/2018 |
| 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="3" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dental caries and Periodontal diseases are the two most
common diseases of the mankind. Dental plaque is the common etiological factor
for both of these disease conditions. apart from mechanical plaque control,
chemical plaque control through the use of mouth rinse may aid as a valuable
adjunct in controlling and the pathogenic microbes in dental plaque which
cause these diseases. many chemical plaque controlling agents were in use, but
with significant side effects like staining of teeth, alteration of taste
perception, dental calculus build up, allergic reactions in the oral cavity,
development of white patches etc. thus a natural and culturally acceptable,
cost-effective chemical agents which has less or no side effects is desirable
in this context. red ginseng is one such product which has proven systemic
benefits and has been used for various systemic diseases . this intervention
study therefore aims to measure the benefits of red ginseng extract containing
mouth rinse against gingivitis and gingival bleeding. chlorhexidine gluconate
and sodium fluoride mouth rinses served as positive controls. 90 patients
are to be recruited with 30 patients in each of the 3 groups. 1st group was
given the red ginseng extract containing mouth rinse, 2nd group was given
Chlorhexidine gluconate mouth rinse and 3rd group was given Sodium Fluoride
mouth rinse. informed consent will be obtained from the patients before
recruiting them for the study. outcome variables measured were Index values of
Plaque Index and gingival index at baseline, 2 weeks, 4 weeks and at 6 weeks.
the test mouth rinse, red ginseng extract containing mouth rinse is expected to
have beneficial effects in reducing the disease process and thereby show a
reduction in the index values as compared tto the baseline value. |