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CTRI Number  CTRI/2019/09/021180 [Registered on: 11/09/2019] Trial Registered Prospectively
Last Modified On: 06/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   effectiveness of diet (sugar intake) modification,tooth brushing and fluoride toothpaste on tooth decay in children 
Scientific Title of Study   Effectiveness of Diet(sugar intake) Modification, Plaque Control and Fluoride Toothpaste on Tooth Remineralization in Children. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAkshata Agnihotri 
Designation  Post Graduate Student 
Affiliation  SDM College of Dental Science  
Address  Department of Pulic Health Dentistry,SDM Dental College Sattur,Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9620996149  
Fax    
Email  aims.akshata28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preetha J Shetty  
Designation  Head of the Department 
Affiliation  SDM College of Dental Science  
Address  Department of Pulic Health Dentistry,SDM Dental College Sattur,Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9845009979  
Fax    
Email  shetty.preetha@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Akshata Agnihotri 
Designation  Post Graduate Student 
Affiliation  SDM College of Dental Science  
Address  Department of Pulic Health Dentistry,SDM Dental College Sattur,Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9620996149  
Fax    
Email  aims.akshata28@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Dental sciences, sattur Dharwad -580009 
 
Primary Sponsor  
Name  Akshata Agnihotri 
Address  Department of Pulic Health Dentistry,SDM Dental College Sattur,Dharwad -580009 
Type of Sponsor  Other [Self ] 
 
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 
Akshata Agnihotri  SDM College Of Dental Science   Department of Pulic Health Dentistry,SDM Dental College Sattur,Dharwad-580009
Dharwad
KARNATAKA 		 9620996149

aims.akshata28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
shri dharmasthala manjunatheshwara college of dental science instututional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Demineralisaled tooth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diet(sugar intake) modification  The modification of the Diet (sugar intake ) will be done via Diet counselling for three months of duration  
Intervention  fluoridated toothpaste  the subjects will be given the commercially avaliable fluoridated toothpastes to use for three months of duration  
Comparator Agent  Plaque control measures  subjects will be instructed to brush their teeth twicw a day for three months via health education and demonstration methods  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1)The Subjects willing to participate in the study and whose parent/guardian willingly sign the informed consent form.
2) The Subjects free from any systemic diseases.
3) The Subjects showing signs of early demineralization with DIAGNOdent Pen reading more than 12 and less than 25.
 
 
ExclusionCriteria 
Details  1)The Subjects showing no signs of early demineralization.
2) The Subjects not willing to participate in the study.
3) The Subjects suffering from systemic diseases.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
remineralisation of initial dental caries lesion   6 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
remineralisation of initial dental caries lesion at 6 weeks and 12 weeks   6 weeks and 12 weeks  
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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   N/A 
Date of First Enrollment (India)   28/09/2019 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nill 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study aims to measure and compare the remineralizing potential of three interventions – Diet (Sugar Intake) modification, Plaque control by instructed tooth brushing,oral rinsing and Use of Fluoride toothpaste – on the tooth structure of children.A total number of  108 subjects  aged 13 to 15 years fulfilling the inclusion criteria and who are willing to participate in the study and whose parents/guardian sign the  inform consent form will be recruited in the study. At the baseline visit, DIAGNOdent Pen reading will be recorded and the subjects will be allotted into three groups according to the DIAGNOdenta Pen scoring as follows:
Group 1: diet(sugr intake) modification-subjects will be advised to reducethe amount and frequency of sugar intake,Subjects will be instructed to follow their usual oral hygiene practices
Group 2: dental plaque control-the subjects are instructed to brush twice daily in the instructed and demonstrated  tooth brushing technique  at the baseline visits.The subjects will also be advised to rinse his/her mouth thoroughly with water after every meal.
Group 3:commercially avaliable fluoride toothpaste will be given to the subjects.The technique of tooth brushing will not be demonstrated as the subjets will be asked to continue their normal oral hygiene practices 
The subjects will be called after 6th week abd 12th week to re-evaluate the DIAGNOdent scores,To ascertain the compliance of the subjects the parents/guardians will be recalled and instructed reguarly.
STATISTICAL ANALYSIS:Data collected will be subjected to statistical analysis using repeated measure ANOVA test and Friedman test to compare the effectiveness of diet modification,dental plaque control and fluoride toothpaste on tooth  remineralisation.

 


 
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