FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055502 [Registered on: 21/07/2023] Trial Registered Prospectively
Last Modified On: 17/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Anti caries effect of three different varnishes on Milk teeth 
Scientific Title of Study   Comparative cariostatic strategy of fluoride varnish, 38% silver diamine fluoride with 20% Potassium iodide solution in primary teeth - a clinical follow-up 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  Dr Shweta Kajjari 
Designation  Reader 
Affiliation  KLE V.K.Institute of Dental Sciences,Belagavi 
Address  Dr Shweta Kajjari,Reader,Department of Pediatric and Preventive Dentistry,KLE V.K.Institute of Dental Sciences,Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9964525733  
Fax    
Email  drshwetakajjari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivayogi M.Hugar 
Designation  Professor and Head 
Affiliation  KLE V.K.Institute of Dental Sciences,Belagavi 
Address  Department of Pediatric and Preventive Dentistry,KLE V.K.Institute of Dental Sciences,Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9986436448  
Fax    
Email  dr.hugarsm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Kajjari 
Designation  Reader 
Affiliation  KLE V.K.Institute of Dental Sciences,Belagavi 
Address  Room no 6,Department of Pediatric and Preventive Dentistry,KLE V.K.Institute of Dental Sciences,Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9964525733  
Fax    
Email  drshwetakajjari@gmail.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research, Nehru nagar,Belagavi 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and ResearchBelagavi 
Address  Department of Pediatric and Preventive Dentistry, KLE V.K.Institute of Dental Sciences, KLE Academy of Higher Education and Research,Nehru nagar,Belagavi 
Type of Sponsor  Research institution and hospital 
 
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 Shweta Kajjari  KAHERS KLE V.K Institute of Dental Sciences, Belagavi  Department of Pediatric and Preventive Dentistry,Room no 6, KLE V.K.Institute of Dental Sciences, KLE Academy of Higher Education and Research,Nehru nagar,Belagavi
Belgaum
KARNATAKA 		 9964525733

drshwetakajjari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE V. K. Institute of Dental Sciences,Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  38% Silver Diamine Fluoride  38% Silver Diamine Fluoride application orally to the cavities once at baseline and follow-up for 1month,3month and 6month 
Intervention  38% Silver Diamine Fluoride with 20% Potassium Iodide Solution  Application Of 38% Silver Diamine Fluoride and 20% Potassium Iodide Solution orally to all cavities once at baseline and follow-up for 1month,3month and 6month 
Comparator Agent  Fluoride Varnish  5% Sodium fluoride varnish application orally to all cavities once at baseline and follow-up for 1month,3month and 6month 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Teeth having caries involving enamel and dentin of first and second deciduous molars in age group between 3years-8years of children with dental Caries

2.Children had to have at least 1 carious lesion as defined by the International Caries Detection and Assessment System II (ICDAS II). Using ICDAS II, Code 3,4 (Non-cavitated lesions) and code 5(cavitated lesion) will be included in the study
(Code 3- Localized enamel breakdown without clinical visual signs of dentinal involvement seen when wet and after prolonged drying, Code 4- Underlying dark shadow from dentine ,Code 5-Distinct cavity with visible dentine)

3.Absence of symptoms indicative of pulpal inflammation such as spontaneous pain and history of nocturnal pain

4.No clinical or radiographical evidence of pulp pathology.

 
 
ExclusionCriteria 
Details  1.Children allergic to silver

2.Non-restorable grossly decayed teeth

3.Primary molars having spontaneous pain, swelling or fistula

4.Mobility of the tooth present

5.Teeth with pathological root resorption namely internal or external root resorption.

6.Developmental defects such as amelogenesis imperfecta or dentinogenesis imperfecta

7.Patients/ parents unwilling to participate in the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the caries reduction after application of Fluoride Varnish, 38% Silver Diamine Fluoride, 38% Silver Diamine Fluoride with 20% Potassium Iodide Solution on primary teeth   Caries reduction will be assessed after application of Fluoride Varnish, 38% Silver Diamine Fluoride, 38% Silver Diamine Fluoride with 20% Potassium Iodide Solution on primary teeth after baseline,1 month, 3 months and 6 months interval 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 4 
Date of First Enrollment (India)   01/08/2023 
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  

Early Childhood Caries is a major dental disease affecting 60%-90% of children worldwide. The traditional way to manage Early Childhood Caries involves removal of infected part followed by filling the cavity to restore the function and aesthetics of the tooth. However, young or apprehensive children are not able to cooperate for lengthy and complex restorative procedures. When the literature search was carried out in past three months, it was seen that there are a few studies carried out comparing the effectiveness of Sodium Fluoride Varnish and Silver Diamine Fluoride in arresting early childhood caries in children. Hence, with this lacunae the present study is being designed to compare the  cariostatic strategy of fluoride varnish, 38% silver diamine fluoride with 20% potassium iodide solution in primary teeth- a clinical follow-up study. This is an in vivo, double-blinded,  triple arm, randomized controlled study in children. The study will be conducted in  different Schools of Belagavi, Karnataka. Participants who will fulfill the inclusion and exclusion criteria shall be selected for the study. Data will be Statistically Analyzed by ANOVA . Groups of samples will be assessed clinically using tactile and visual inspection for 1month,3 month and 6 month follow-up. Follow-up will be done for color of carious lesion(yellow, brown and black),consistency(hard, medium and soft),arrested lesions and new active lesions.

 
Close