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CTRI Number  CTRI/2024/08/072862 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [ALTERNATIVE RESTORATIVE PROCEDURE V]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Assess the Effectiveness of Silver Diamine Fluoride with Glass Ionomer Cement in Differently Abled Children 
Scientific Title of Study   To assess the effectiveness of silver diamine fluoride application with delayed glass ionomer cement restoration in dentinal caries of differently abled children An in-vivo 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 Shashwath K 
Designation  Post Graduate 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet Kodagu

Kodagu
KARNATAKA
571218
India 
Phone  8762118374  
Fax    
Email  shashwathk1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shanthala B M 
Designation  Professor and Head 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet Kodagu

Kodagu
KARNATAKA
571218
India 
Phone  9901452918  
Fax    
Email  shanthalapedo@cids.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shashwath K 
Designation  Post Graduate 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus, Maggula Virajpet Kodagu

Kodagu
KARNATAKA
571218
India 
Phone  8762118374  
Fax    
Email  shashwathk1997@gmail.com  
 
Source of Monetary or Material Support  
Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus, Maggula Virajpet Kodagu District Karnataka 571218 
 
Primary Sponsor  
Name  Dr Shashwath K 
Address  Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus, Maggula Virajpet Kodagu District Karnataka 571218 
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 Akshatha S  Coorg Institute of Dental Sciences  Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus, Maggula Virajpet Kodagu District Karnataka 571218
Kodagu
KARNATAKA 
7975149377

shivaakshatha3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD COORG INSTITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  SPECIAL CHILDREN 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Silver Diamine Fluoride  Silver Diamine Fluoride used to arrest the caries process in a tooth over a period of time. In this study restoration is followed after 2 weeks of Intervention applied. Hence Comparator agent is not applicable .  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1.Differently abled children
2.Age between 3 -14 years will be selected
3. Selected subject should have dentinal caries involving either Primarymolars /Premolar/Permanent molars belonging to ICDAS score 4 and 5
 
 
ExclusionCriteria 
Details  1.Enamel caries and caries involving pulp
2.Systemically healthy children with no physical and mental disabilities
3.Differently abled children less than 3 years and above 14 years.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Arrest of Progression of Caries  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
As a Control of Dental Caries Consequences in the Tooth  3 Years 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   02/09/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response (Others) -  For continuing Research

  5. By what mechanism will data be made available?
    Response (Others) -  Through publication in the scientific journal as manuscript

  6. For how long will this data be available start date provided 27-07-2024 and end date provided 27-07-2041?
    Response (Others) -  Indefinitely

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Dental caries continues to be one of the most prevalent chronic diseases in the world, affecting people across all age groups and countries . The oral health of differently abled children may be affected due to untreated dental conditions resulting from inadequate diagnosis or limited access to dental services . It’s acknowledged that differently abled children encounter distinct obstacles when pursuing preventive and restorative dental care . The presence of intricate physical and medical conditions, coupled with behavioural challenges, can complicate the process of diagnosis and treatment. Consequently, parents or caregivers face increased difficulty in fulfilling their role in providing daily preventive care .

The association between fluoride and dental practice, as well as preventive dentistry, spans over two centuries, as evidenced by historical documents indicating a potential correlation between fluoride and caries . Future studies are directed towards enhancing the antimicrobial and anti-degradative characteristics of existing restoration materials  by modifying their composition, with the goal of minimizing microbial adherence and biofilm formation .

Silver diamine fluoride, a solution comprising silver nitrate and fluoride, serves as both an antibacterial and remineralizing agent. By diminishing biofilm counts and impeding collagen degradation, the product promotes the remineralization of enamel and dentin, effectively halting the advancement of caries .

Silver diamine fluoride (SDF) plays a crucial role in caries management, particularly for children at high risk of caries, individuals with medical complexities, those facing behavioural challenges, and those encountering barriers to accessing dental care .

The mechanism of action of SDF relies in its ability to react with hydroxyapatite to generate fluorapatite, which prevents or lessens any future caries. When SDF is administered, it penetrates both the enamel and dentin, stocking the tooth with nearly twice as much subsurface fluoride as other fluoride forms . However, the primary drawback of SDF lies in its tendency to stain caries lesions, primarily attributable to the silver compounds present in the solution. This staining effect has contributed to the limited acceptance of SDF within the dental community .

The success and durability of dental restorations rely on various critical factors. Among them, establishing a robust bond between the restorative material and the tooth substrate is vital, encompassing not only mechanical considerations but also biological and aesthetic aspects . Chemical bonding to both enamel and dentin distinguishes glass ionomer cements (GICs) from others, by interactions involving hydroxyapatite and polycarboxylate radicals .

Applying GIC immediately following SDF application results in tooth discoloration, whereas delaying GIC restoration for two weeks after SDF application minimizes discoloration .

This study aims at assessing the effectiveness of SDF and GIC restoration in dentinal caries in differently abled children.

 
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