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CTRI Number  CTRI/2024/10/075418 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparision of potassium iodide added silver diamine flouride and silver fluoride in treatment of class 2 early childhood caries 
Scientific Title of Study   Comprehensive evaluation of potassium iodide added silver diamine fluoride and silver fluoride in stage-II Early childhood caries- A clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Revanuru Swathi 
Designation  PG Student 
Affiliation  K V G Dental college and hospital  
Address  Room no- 10 Department of pediatric and Preventive dentistry KVG dental college and Hospital Sullia DK Kurunjibagh Karnataka India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9620424264  
Fax    
Email  swathi.revanuru@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishnamoorthy S H 
Designation  Professor 
Affiliation  K V G Dental college and hospital  
Address  Room no- 10 Department of pediatric and Preventive dentistry KVG dental college and Hospital Sullia DK Kurunjibagh Karnataka India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9964428004  
Fax    
Email  kmoorthysh21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishnamoorthy S H 
Designation  Professor 
Affiliation  K V G Dental college and hospital  
Address  Room no- 10 Department of pediatric and Preventive dentistry KVG dental college and Hospital Sullia DK Kurunjibagh Karnataka India

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9964428004  
Fax    
Email  kmoorthysh21@gmail.com  
 
Source of Monetary or Material Support  
K V G Dental college and hospital Sullia DK India Pincode 574327 
 
Primary Sponsor  
Name  Dr Revanuru Swathi 
Address  Room No 10 Department of Pediatric and Preventive dentistry KVG Dental college and Hospital Sullia DK Karnataka 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 Revanuru Swathi  KVG Dental college and hospital  Room No 10 Department of Pediatric and Preventive dentistry KVG Dental college and hospital Sullia Dakshina kannada Karnataka India 574327
Dakshina Kannada
KARNATAKA 
9620424264

swathi.revanuru@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee KVG Dental college and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Potassium iodide added Silver Diamine Fluoride  A protective coating of petroleum jelly will be applied to the lip and mucosa and the affected area will be gently cleaned and dried with cotton gauze. Isolation of the affected area with the help of cotton rolls will be done followed by etching with 37% phosphoric acid. After 60secs the etched surface will be rinsed with water and dried. Then the etched surface is coated with 38% SDF over the carious surface with the help of a micro brush. Immediately followed by the application of KI using a separate micro brush until the precipitate changes from yellow to white and then clear. Applied area will be kept isolated for 2mins and then gently rinsed with water. This step is followed by GIC restoration. Clinical photographs and radiographs post procedure will be taken. Duration of the whole procedure will be 30mins 
Intervention  Potassium iodide added Silver fluoride   A protective coating of petroleum jelly will be applied to the lip and mucosa and the affected area will be gently cleaned and dried with cotton gauze. Isolation of the affected area with the help of cotton rolls will be done followed by etching with 37% phosphoric acid. After 60secs the etched surface will be rinsed with water and dried. Then the etched surface is coated with 38% AgF with a microbrush. Immediately followed by the application of KI using a separate micro brush until the precipitate changes from yellow to white and then clear. Applied area will be kept isolated for 2mins and then gently rinsed with water. This step is followed by GIC restoration. Clinical photographs and radiographs post procedure will be taken. Duration of the whole procedure will be 30 minutes. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Active carious lesions which have ICDAS code 3 - 5.
Teeth selected as per ICCMS score 2 to 4.
Children who meet the Lampshire classification for cooperation.
Children with parental consent.
 
 
ExclusionCriteria 
Details  Children with spontaneous pain or any signs of pulpal infection.
Children having any clinical or radiographic signs of periapical infection.
Active carious lesions which have ICDAS codes 5 and 6.
Children who have sensitivity to silver or other heavy metal ions.
Children with any gingival or perioral ulceration or stomatitis.
Children falling under ICCMS score other than 2 and 4.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To clinically evaluate and compare the tooth discoloration caused by 38% SDF added potassium iodide and 38% AgF added potassium iodide.  Baseline, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To clinically and radiographically evaluate and compare the caries progression with 38% SDF added potassium iodide and 38% AgF added potassium iodide.
To clinically evaluate and compare the duration of application of both the materials. 
Baseline, 6 months 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   01/02/2025 
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 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  

Early Childhood Caries (ECC) is used to denote the occurrence of one or more primary teeth, in a child under the age of 6, that are decayed, restored, or missing. ECC has 4 stages, wherein any failure to address the initial reversible lesion will progress to the traumatic stage. In the traumatic stage of ECC, the teeth become so weak by caries that they fracture on minor trauma. Hence importance has to be given for the early reversal of the lesion and its arrest. ECC when left untreated results in pain, irritability, bacteremia, high treatment costs, reduced growth and development, speech disorders, and premature tooth loss with its sequelae of compromised chewing, loss of self-esteem, and permanent dentition hampering their mental attitude. 44% of children aged between 8 and 48 months have ECC in India. According to McDonald and Avery, the major three steps in preventing ECC are decreasing substrate concentration, decreasing microbial load, and increasing resistance of the tooth.6 Traditionally, the approach to managing carious lesions involves mechanical removal of the decayed tissue and replacing it with an appropriate restorative material. The treatment success with traditional approaches is highly influenced by the child’s behavior in the dental setting. As an alternative Minimal invasive dentistry (MID), which aims at maintenance of the sound tooth structure using non-invasive techniques has replaced the conventional procedures. Carol Anne et al, say that the “minimally invasive” approach to treating dental caries incorporates the dental science of detecting, diagnosing, intercepting, and treating dental caries on the microscopic level. ART, PRR, and SMART are among the many nonsurgical methods used in this approach to treating dental caries.SDF adheres to the philosophy of minimally invasive dentistry. Stebbins utilized SDF for the first time in 1969, and Japan approved it in August 2014 for therapeutic usage. SDF contains silver which is bactericidal and is used as an antimicrobial agent to arrest caries. It can be utilized extensively in pediatric dentistry since it is non-invasive, especially for children with unique healthcare needs and recalcitrant behavior, where traditional treatments can be technique-sensitive. It acts by obstructing dentinal tubules, promoting demineralized teeth to become more mineralized, and preventing the breakdown of dentinal collagen. The primary disadvantages of silver diamine therapy are the black stain left by the silver content and the strong taste and odor of ammonia, which also slightly irritates soft tissues. Studies were done on the effects of varying concentrations of silver diamine fluoride in arresting dental caries, but there is a dearth of information on how to prevent the tooth structure from discoloration after a procedure, cover up the smell, and lessen pain in the soft tissues. To prevent discoloration, our study applies potassium iodide (KI) after applying 38% silver fluoride with water as a solvent to overcome the soft tissue discomfort caused by ammonia. Thus this study aims to compare conventional 38% SDF added potassium iodide with 38% AgF added potassium iodide with water as a solvent.

 
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