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CTRI Number  CTRI/2023/09/057884 [Registered on: 20/09/2023] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of two protocols to prevent dental caries in special children 
Scientific Title of Study   Efficacy of silver diamine fluoride versus silver diamine fluoride & fluoride varnish in arresting dental caries in special children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sukhdeep Singh 
Designation  Professor 
Affiliation  School of dental sciences, Sharda University 
Address  Head, Dept. of Pediatric and preventive dentistry, School of dental sciences, Sharda University

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9971808787  
Fax    
Email  sukhdeep.singh@sharda.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Sukhdeep Singh 
Designation  Professor 
Affiliation  School of dental sciences, Sharda University 
Address  Head, Dept. of Pediatric and preventive dentistry, School of dental sciences, Sharda University


UTTAR PRADESH
201306
India 
Phone  9971808787  
Fax    
Email  sukhdeep.singh@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Sukhdeep Singh 
Designation  Professor 
Affiliation  School of dental sciences, Sharda University 
Address  Head, Dept. of Pediatric and preventive dentistry, School of dental sciences, Sharda University


UTTAR PRADESH
201306
India 
Phone  9971808787  
Fax    
Email  sukhdeep.singh@sharda.ac.in  
 
Source of Monetary or Material Support  
School of dental sciences, Sharda University 
 
Primary Sponsor  
Name  School of dental sciences, Sharda University 
Address  Plot 32-34, Knowledge Park-3, Greater Noida-201306, U.P. 
Type of Sponsor  Other [Private dental college 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 
Sukhdeep Singh  School of dental sciences  Sharda University, Plot 32-34, Knowledge park-3, Greater Noida-201306
Gautam Buddha Nagar
UTTAR PRADESH 
9971808787

sukhdeep.singh@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, School of medical sciences and research and Sharda hospital  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 and 2% fluoride varnish  38% Silver diamine fluoride (SDF)will be topically applied on the decayed teeth as per manufacturers instructions followed by the topical application of 2% sodium fluoride NaF on the entire dentition. 
Intervention  Fluoride varnish  2% Sodium fluoride NaF varnish meant for topical use in dentistry will be applied on all the teeth of the child as per manufacurers instructions. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Special children aged 4 years to 14 years with dental decay will be selected 
 
ExclusionCriteria 
Details  Special children below 4years and above 14 years and those with no dental decay will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical evidence of dental decay arrest. Conversion of Nyvad scale 1, 2, and 3 to 4, 5, 6.  Clinical evidence of dental decay arrest. Conversion of Nyvad scale 1, 2, and 3 to 4, 5, 6. 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical evidence of non arrest of dental decay. Any clinical evidence of worsening of the existing dental decay in terms of pain/abcess  6 months, 12 months, 18 months. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Dental caries has been around for time immemorial. It is a microbial infectious disease and probably the most significant chronic childhood disease prevalent globally. It can lead to a high level of morbidity and affect the quality of life in many ways. It is a secular infectious disease cutting across all sections of society in both developed and developing nations. Some of the consequences of untreated lesions are pain, swelling, fever, inability to eat, malnutrition, difficulty in speech and tooth loss.

A lot has changed in the recent past in understanding the science of dental caries, its prevention and treatment but data from across the world shows that dental caries remains a serious disease globally.

The level of awareness in caregivers (parents and non dental healthcare providers) regarding the symptoms, treatment (especially of untreated lesions) and prevention of dental caries remains low. This leads to a huge burden of care on the society.


Special health care needs children are at a much higher risk of developing dental caries because of their inherent challenges of carrying our even simple acts like tooth brushing. Added to this is also the fact that most of the parents of special children may be focused on seeking and providing seemingly more important medical care to their child/children which leads to a neglect of dental care. Medical care in special children may also involve administering medications in a sweetened syrup form which are mostly sugar based. Lack of awareness regarding caries prevention amongst parents leads to dental caries in such children. Special children are often on pureed diets which are more cariogenic and need special preventive protocols often found missing. Added to these is the fact that special children need a different approach for their dental treatment and hence not all dentists are able to competently treat special children. More often than not this also entails higher treatment costs which become a constraint for many parents leading to a neglect of dental caries. This may become a vicious cycle and end in serious morbidity and tooth loss.

Over time numerous preventive strategies and protocols have been tried and tested by the dental fraternity of researchers and clinicians. Literature is replete with many examples and two stand out in recent times. These are topical application of fluoride varnish (FV) and silver diamine fluoride (SDF). Many studies have been conducted on both the protocols and there are meta analysis and systematic reviews too, explaining the evidence on their efficacy. Both protocols work.


Traditionally fluoride varnish has been extensively used in the prevention of dental caries. SDF has proven itself to be a effective measure in arresting decay, hence the interest in its use in special children. Very few relevant studies exist in the literature where in SDF has been studied in special children, either alone or with fluoride varnish.

This trial will try and bridge this gap.

 
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