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CTRI Number  CTRI/2024/08/072689 [Registered on: 19/08/2024] Trial Registered Prospectively
Last Modified On: 17/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare salivary fluoride concentrations from conventional and iontophoresis-infused topical fluoride gel usage among 8-12 year old children to prevent tooth decay. 
Scientific Title of Study   Comparative Evaluation of Salivary Fluoride Concentration from Conventional Topical Fluoride Gel Application and Topical Fluoride Gel Infused via Iontophoresis among 8–12 Year Old Children: A Randomised Clinical Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Janvi Manish Dave 
Designation  Post graduate student 
Affiliation  KM shah Dental College 
Address  Room no 3 Department of Pediatric and Preventive Dentistry KM shah Dental college Sumandeep Vidyapeeth Piparia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9082173008  
Fax    
Email  davejanvi401@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhavna Dave 
Designation  Professor and Head of the Department 
Affiliation  KM shah Dental College 
Address  Room no 3 Department of Pediatric and Preventive Dentistry KM shah Dental college Sumandeep Vidyapeeth Piparia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9998034036  
Fax    
Email  bhavnadave1964@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Janvi Manish Dave 
Designation  Post graduate student 
Affiliation  KM shah Dental College 
Address  Room no 3 Department of Pediatric and Preventive Dentistry KM shah Dental college Sumandeep Vidyapeeth Piparia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9082173008  
Fax    
Email  davejanvi401@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  DrJanvi Dave 
Address  Room no 3 Department of Pediatric and Preventive dentistry KM Shah dental college and hospital sumandeep vidyapeeth Piparia Vadodara, Gujarat 391760, India 
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 
Dr Janvi Dave  KM Shah dental college and hospital  Room no 3 Department of Pediatric and Preventive Dentistry
Vadodara
GUJARAT 
9082173008

davejanvi401@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children at risk of developing dental caries or children with intial signs of dental caries(ICDAS score 0 to 2) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional 1.23%APF gel application  1.23% is Topical fluoridated product and is able to create reservoirs, providing bioavailability of the product for the dental surface which is effective in reducing demineralization and increasing remineralization. To check the efficacy of Intervention group the fluoride application via conventional technique will be used 
Intervention  Iontophoreosis infused APF gel application  Iontophoresis is a non-invasive technique, based on the application of a constant low-intensity electric current to facilitate the release of a variety of drugs, through the biological membranes. Iontophoresis enhances the delivery of both charged and uncharged drugs by the application of an electric current across a membrane. Iontophoresis has a wide range of application in dentistry, to produce a non-invasive technique of anaesthesia, iontophoresis of fluoride to decrease dentinal hypersensitivity, iontophoresis of peroxide for teeth whitening and that of nano-particles for re-mineralization of decalcified enamel and dentin are among the others. Thus, in this study APF gel will be infused via iontophorosis for 4 minutes and fluoride uptake will be assessed by Salivary Fluoride levels will be assessed at 60 minutes, 24 hours and 1 week after fluoride application. 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children reporting to the Out-Patient- department accompanied by their parents within the
age group of 8-12 years.Children with FRANKL’s 3 AND 4 behaviour rating scale will be
included.Children with ICDAS score upto 2 
 
ExclusionCriteria 
Details  Children who are medically compromised and those with special health care needs.Children with dental fluorosis. Children with previous dental restorations. Children who’s parents do not provide consent 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate Salivary
level by infusing
fluoride gel via
Iontophorosis 
Baseline, At 60 minutes, At 24 hours and At 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
To achieve more
efficient methods
for caries
prevention. 
1 month 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   28/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Fluorides have been at the forefront of preventive dentistry ever since their anticariogenic potential was discovered. Topical fluoridated products are able to create reservoirs, providing bioavailability of the product for the dental surface which is effective in reducing demineralization and increasing remineralization. Iontophoresis is a non-invasive technique, based on the application of a constant low-intensity electric current to facilitate the release of a variety of drugs, through the biological membranes. Iontophoresis enhances the delivery of both charged and uncharged drugs by the application of an electric current across a membrane. Iontophoresis has a wide range of application in dentistry, to produce a non-invasive technique of anaesthesia, iontophoresis of fluoride to decrease dentinal hypersensitivity, iontophoresis of peroxide for teeth whitening and that of nano-particles for re-mineralization of decalcified enamel and dentin are among the others. Fluoride levels in whole saliva can be affected by method of delivery, and generally follows the same pattern in plaque samples. Although salivary retention of fluoride does not necessarily reflect anticaries effect, this data can provide some indication of dose- effective methods of topical fluoride application. Barbakow in 19738 suggested that fluoride concentration were greater after the iontophoretic applications Recent invitro studies suggest tha there is increased uptake of fluoride in teeth after iontophoresis. Thus, it is vital to investigate improved fluoride administration systems.


 
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