| CTRI Number |
CTRI/2025/02/080834 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Arrowroot Extract and Chlorhexidine Mouth Rinses on Oral Bacteria in Young Adults: A Clinical Study |
|
Scientific Title of Study
|
Antibacterial Efficacy of Maranta Arundinacea (Arrowroot) Extract mouth rinse and Chlorhexidine mouth rinse against Salivary Streptococcus mutans among young adults:
A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMA RANI M |
| Designation |
Second year Postgraduate |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308 |
| Address |
Department of public health dentistry
Room no 8
Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308
Department of public health dentistry
Room no 8
Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9994676302 |
| Fax |
|
| Email |
muraliuma14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.N.SARAVANAN |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308 |
| Address |
Department of public health dentistry
Room no 8
Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308
Department of public health dentistry
Room no 8
Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9442262950 |
| Fax |
|
| Email |
drsaravananphd@vmsdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
UMA RANI M |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308 |
| Address |
Department of public health dentistry Room no 8 Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308
Department of public health dentistry Room no 8 Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9994676302 |
| Fax |
|
| Email |
muraliuma14@gmail.com |
|
|
Source of Monetary or Material Support
|
| UMA RANI M
Second year Postgraduate
Department of public health dentistry
Room no 8
Vinayaka Missions Sankarachariyar Dental college. Sankari Main Road, Ariyanur, Salem, Tamil Nadu, India . 636308 |
|
|
Primary Sponsor
|
| Name |
Dr Uma Rani |
| Address |
Vinayaka missions sankarachariyar dental college Salem |
| Type of Sponsor |
Other [principal investigator] |
|
|
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 Uma Rani |
Alagappa University |
College of physical education
Alagappa University
Karaikudi Sivaganga
Sivaganga
TAMIL NADU |
09994676302
muraliuma14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of VMS dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouth rinse |
Commercially available 0.2% CHX solution (Hexidine ICPA Health products)
will be diluted to a 1:1 concentration. |
| Comparator Agent |
Distilled water Placebo group |
It will be formulated with the same color and taste of the other mouth rinses. |
| Intervention |
Maranta Arundinacea (Arrowroot) Extract mouth rinse |
The Extraction process will be carried out using Soxhlet apparatus by mixing powder with various solvents (Pet Ether, Chloroform, Acetone, Alcohol, Aqueous) of different polarities. The clear filtrate will be obtained by filtering it through Whatman No:1 filter paper filtrates will be evaporated and stored at 4oC in an air tight container |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Students with no history of any dental treatment for last 3 months.
2.Students with no use of antibiotic or anti-inflammatory drug therapy for the past 3 months
3.Students with no history of systemic diseases.
4.Students with baseline plaque score greater than 2 and a baseline Decayed, Missing and Filled teeth (DMFT) score of 3 to 5
|
|
| ExclusionCriteria |
| Details |
1.Students who are not willing to take part in the study
2.Students who are currently using any mouthwash and oral hygiene aids.
3.Students who are allergic to any mouthwash.
4.Students who are using any prostheses or appliances. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reducing salivary streptococcus mutans |
day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Natural alternative for reducing dental caries risk |
day 14 |
|
|
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 1 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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: Antibacterial Efficacy of Maranta Arundinacea (Arrowroot) Extract mouth
rinse and Chlorhexidine mouth rinse against Salivary Streptococcus mutans among
young adults: A Randomized Controlled Trial
Background:
Oral diseases, including dental caries and periodontal disease, are significant
global public health challenges strongly linked to bacterial etiology. While
herbal mouth rinses show potential as effective alternatives, there is limited
scientific evidence supporting their efficacy.
Introduction:
The growing concerns over adverse effects associated with synthetic drugs have
driven interest in plant-based remedies. Maranta Arundinaecea
(Arrowroot) is known for its antioxidant, anti-inflammatory, and potential
antibacterial properties, making it a promising candidate for oral health
applications.
Aim:
The study will aim to Evaluate the antibacterial Efficacy of M. Arundinacea
Extract mouth rinse and Chlorhexidine (CHX) mouth rinse against Salivary
Streptococcus mutans among young adults
Objectives:
- To formulate and evaluate an antibacterial mouth rinse using M.
Arundinaecea extract.
- To test and compare the antibacterial activity of M. Arundinaecea
extract mouth rinse with CHX against Porphyromonas gingivalis.
- To measure and compare the reduction in salivary S. mutans
before and after using M. Arundinaecea extract mouth rinse and CHX
mouth rinse.
Material and Methods:
The trial will include 90 young adult participants based on the inclusion and
exclusion criteria. The are randomized into three groups (placebo, M.
Arundinaecea extract mouth rinse, and CHX mouth rinse). Saliva samples will
be collected at baseline (Day 1) and post-intervention (Day 14). Salivary S.
mutans levels will be assessed to evaluate and compare the antibacterial
efficacy. |