CTRI Number |
CTRI/2015/08/006070 [Registered on: 03/08/2015] Trial Registered Retrospectively |
Last Modified On: |
15/02/2016 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
EFFECT OF HERBAL AND FLUORIDE MOUTHRINSES ON DENTAL CARIES AMONG 12 – 15 YEAR OLD SCHOOL CHILDREN IN MANGALORE |
Scientific Title of Study
|
EFFECT OF HERBAL AND FLUORIDE MOUTHRINSES ON STREPTOCOCCUS MUTANS COUNT, GLUCAN SYNTHESIS BY STREPTOCOCCUS MUTANS AND DENTAL CARIES AMONG 12 – 15 YEAR OLD SCHOOL CHILDREN IN MANGALORE – 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 |
DrVinej Somaraj |
Designation |
Post Graduate Student |
Affiliation |
Yenepoya University |
Address |
Yenepoya Dental College
Yenepoya University
Deralakatte
University Road
Mangalore
Karnataka
Dakshina Kannada KARNATAKA 575018 India |
Phone |
8105170815 |
Fax |
|
Email |
v2vinej@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrRekha P Shenoy |
Designation |
Reader |
Affiliation |
Yenepoya University |
Address |
Yenepoya Dental College
Yenepoya University
Deralakatte
University Road
Mangalore
Karnataka
Dakshina Kannada KARNATAKA 575018 India |
Phone |
9845132999 |
Fax |
|
Email |
merekhap@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrVinej Somaraj |
Designation |
Post Graduate Student |
Affiliation |
Yenepoya University |
Address |
Yenepoya Dental College
Yenepoya University
Deralakatte
University Road
Mangalore
Karnataka
Dakshina Kannada KARNATAKA 575018 India |
Phone |
8105170815 |
Fax |
|
Email |
v2vinej@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Dr Vinej Somaraj |
Address |
Yenepoya Dental College
Yenepoya University
Deralakatte, Mangalore,
Karnataka - 575018
India |
Type of Sponsor |
Other [Self Funded] |
|
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 |
Manjunath Bhat |
Muslim Residential School |
Urumanae
Natekal Dakshina Kannada KARNATAKA |
9449937134
mrskotekar@rediffmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Block Educational Officer Permission |
Approved |
Yenepoya University Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Participants with Dental Caries |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
fluoride mouth rinse |
0.2% sodium fluoride – 10ml to be rinsed for 1 minute, fortnightly over a period of 1 year |
Intervention |
herbal mouth rinse |
Freshol – 10ml to be rinsed for 1 minute, fortnightly over a period of 1 year. |
Comparator Agent |
placebo mouth rinse |
10ml to be rinsed for 1 minute, fortnightly over a period of 1 year |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
15.00 Year(s) |
Gender |
Both |
Details |
•Subjects who consent to participate in the study.
•Subjects who are present on the day of examination.
|
|
ExclusionCriteria |
Details |
•Any physical limitations that might preclude normal oral hygiene procedures (i.e. tooth brushing etc)
•Any history of allergy to mouth rinse and toothpaste.
•Subjects under medications such as anti-inflammatory drugs, antibiotics and steroids.
•Subjects with history of gastrointestinal problems.
•Subjects with any pathological conditions requiring emergency treatment.
•Subjects with moderate to severe gingival or periodontal pathologies.
•Subjects who have already undergone any type of topical fluoride application. |
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
EFFECT OF HERBAL AND FLUORIDE MOUTHRINSES ON STREPTOCOCCUS MUTANS COUNT, GLUCAN SYNTHESIS BY STREPTOCOCCUS MUTANS AND DENTAL CARIES AMONG 12 – 15 YEAR OLD SCHOOL CHILDREN |
EFFECT OF HERBAL AND FLUORIDE MOUTHRINSES ON STREPTOCOCCUS MUTANS COUNT, GLUCAN SYNTHESIS BY STREPTOCOCCUS MUTANS AND DENTAL CARIES AMONG 12 – 15 YEAR OLD SCHOOL CHILDREN WILL BE ASSESSED AT BASELINE, 6 MONTHS AND AFTER 12 MONTHS |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="225" Sample Size from India="225"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/09/2014 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The primary pathogen for dental caries is considered to be Streptococcus
mutans. Streptococcus mutans glucosyltransferase (GTF) is
considered a cariogenic virulence factor owing to the ability to synthesise
glucan, which facilitates sucrose dependent adherence and cell-to-cell
accumulation of bacteria. Studies have demonstrated the importance of glucan
synthesis by Streptococcus mutans in the pathogenesis of dental caries. Glucan synthesised in a salivary pellicle promotes selective adherence and
accumulation of cariogenic streptococci on human teeth. Glucan increases the
volume and porosity of biofilm, which enables more substrates to diffuse to
enamel surfaces. Acidogenic bacteria in the deeper layers of the dental biofilm
produce more acid from substrates and hydrogen ions diffuse through the porous
biofilm more rapidly, which enhances the development of dental caries. Fluoride therapy is the corner stone of caries preventive strategies.
The effect of fluoride on the Streptococcus mutans counts has been demonstrated
by studies. Various herbal extracts like chamomile, ocimum and Echinacea are
known to provide therapeutic benefits in the oral cavity when used topically. The need of the study is to
determine whether there is any variation in Streptococcus mutans counts,
glucan synthesis by Streptococcus mutans and dental caries among school
children who receive herbal and fluoride mouth rinses. A randomized controlled trial will be conducted
in randomly selected schools in Mangalore and the study sample will comprise of
225 schoolchildren who fulfil the inclusion and exclusion criteria.
Streptococcus mutans will be identified by using biochemical tests (Catalase test
and sugar fermentation). Glucan synthesis by streptococcus mutans
will be evaluated by Phenol sulphuric acid method. Caries
assessment will done using International Caries Detection and Assessment System
(ICDAS). |