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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).

 
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