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CTRI Number  CTRI/2023/03/050781 [Registered on: 17/03/2023] Trial Registered Prospectively
Last Modified On: 24/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A clinical trial to compare the effect of two treatment methods for restoring primary molar. 
Scientific Title of Study   Comparative evaluation of clinical success on restoring untreated and 38% SDF treated dentine caries lesions in primary molars with the ART approach : A split mouth clinical trial study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ADITYA S NAIK 
Designation  POST GRADUATE STUDENT DEPT OF PEDIATRIC AND PREVENTIVE DENTISTRY. 
Affiliation  GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU 
Address  Room no.5, Department of Pediatric and Preventive Dentistry, Government Dental College and Research Institute, Victoria Hospital campus, Kalasipalayam, near City Market, Bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  8310961649  
Fax    
Email  adityanaik81.an@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR S K SRINATH 
Designation  PROFESSOR AND HEAD OF DEPARTMENT. 
Affiliation  GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Room no.5, Department of Pediatric and Preventive Dentistry, Government Dental College and Research Institute, Victoria Hospital campus, Kalasipalayam, near City Market, Bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  9845592166  
Fax    
Email  srinath.krishnappa@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR SULAKSHANA  
Designation  ASSISTANT PROFESSOR. 
Affiliation  GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Room no.5, Department of Pediatric and Preventive Dentistry, Government Dental College and Research Institute, Victoria Hospital campus, Kalasipalayam, near City Market, Bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  8123184758  
Fax    
Email  drsaanvi20@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE,BENGALURU 
 
Primary Sponsor  
Name  DR. ADITYA S NAIK 
Address  Government dental college and Research Institute, Victoria Hospital campus, Kalasipalayam, near City Market, Bengaluru, Karnataka, 560002 
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 Aditya S Naik  Government Dental College and Research Institute  Room no 5: Department of Pediatric and Preventive dentistry,Government Dental College and Research Institute, Victoria Hospital Campus, Kalasipalayam, near City Market Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9113568836

adityanaik81.an@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of Government Dental College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children between the age group of 4-8 years with asymptomatic bilateral primary molars with dental caries.  
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ART  A split mouth study design will be adopted with 46 participants, who will receive ART on one of the primary molars. ART evaluation criteria is used for clinical evaluation of the restorations at baseline, 6 months and 12 months. 
Intervention  ART with 38% Silver Diamine Fluoride  A split mouth study design will be adopted with 46 participants, who will receive 38% Silver Diamine Fluoride in the first appointment followed by ART after period of 2 weeks. ART evaluation criteria is used for clinical evaluation of the restorations at baseline, 6 months and 12 months. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  All healthy children aged between 4-8 years, of both sexes.
Requiring restorations of bilateral primary molars.
Asymptomatic primary molars with active caries.
ICDAS II Score 5
Cooperative children with Frankel behavior rating scale (FBRS) score of 3 or 4
All participants agreeing to the written informed consent and willing for the same. 
 
ExclusionCriteria 
Details  Children who suffered from serious systemic disease/conditions
Tooth with pulpal involvement/pathology as evident by clinical and radiographic examination.
Caries lesions which were too small for hand instruments to prepare the cavity for a restoration.
Primary molars near exfoliation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical success of modified ART with 38% SDF in comparison to ART.  Clinical evaluation of the restorations at placement, 6 months and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic success and absence of secondary caries.  Radiographic evaluation before placement and after 12 months 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/03/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Need for the study:
Dental caries, continues to be a dental public health issue. With a better understanding of its pathology, it is realized that dental caries should not be treated simply by excavation of carious tissues and studies show that topical application of silver diamine fluoride (SDF) solution is effective in arresting dental caries in young children.38% SDF (44,800 ppm of fluoride and 253,870 ppm of silver) is effective in inhibiting bacterial growth, enhancing remineralization, and arresting caries .
One significant limitation of SDF treatment is that it stains carious lesions black . Furthermore, SDF can only arrest progress of dental caries. The caries cavity is still present and unfilled, which compromises chewing ability and dental plaque control.
Atraumatic restorative treatment (ART) is a minimally invasive operative approach to manage cavitated dentine carious lesions. Soft carious tissues are removed by hand instruments and local anesthesia is seldom needed. The cavity is cleaned and filled with an adhesive dental material.
SDF can be used in conjunction with the ART which would help eradicate cariogenic bacteria whilst promoting remineralisation of the carious lesion.
However, as less comparative studies on SDF in conjunction with ART are available, this study will be undertaken to compare and evaluate the clinical success of ART restorations placed in untreated and SDF-treated dentine caries lesions.

Research Question: Does prior SDF application improve the success rate of ART restorations placed in primary teeth?
Research Hypothesis: Prior SDF application improves the success rate of ART restorations placed in primary teeth.

Methodology


   The present in vivo study will be conducted in the Department of Pedodontics and Preventive Dentistry, Government Dental College and Research Institute, Bangalore. Children between the age group of 4-8 years, with cooperative behavior(Frankel Behavior Rating Scale-FBRS of 3 and 4) coming to the department with asymptomatic bilateral primary molars with dental caries without any unfavorable medical history will be selected for the study. Prior to the procedure, the possible discomfort, risks and benefits will be explained and informed consent will be obtained from the parents. 

·          The International Caries Detection and Assessment System  II (ICDAS II)

CODE

FEATURES

Code 1

Smooth tooth surfaces.

Code 2

Distinct visual change in enamel.

Code 3

Localized enamel breakdown because of caries with no visible dentin or underlying shadow.

Code 4

Underlying dark shadow from dentin with or without localized enamel breakdown.

Code 5

Distinct cavity with visible dentin.

Code 6

Extensive distinct cavity with visible dentin.

·         A split mouth design will be adopted where all patients will receive 38% SDF followed by ART Restoration - Group A (experimental group) and ART restorations - Group B(control group) on either side  primary molar which will be randomly assigned.

The other dental procedures, if any, are required for the child, will be addressed simultaneously along with the study protocols.

Pre operative radiograph will be taken before the procedure.

Group A - In the first appointment, 38% SDF will be applied by the operator trained to perform the procedure.

·        The tooth will be washed and dried. Rubber dam will be placed prior to SDF application to isolate the tooth, to prevent saliva contamination and to protect gingivae from contacting excessive solution.

·         The Operator will dip micro-applicator brush in 38% SDF solution (Kids-e-dental, India)  and the solution will be applied according to the manufacturer’s instruction .Using the microapplicator brush ,the carious tooth structure will be coated with the solution. The solution will be allowed to dry for 3 minutes. The excess solution will be cleaned using a cotton swab.

·         The children will be instructed not to eat or drink for half an hour.

Group B – Carious cavity will be restored with the use of ART approach  using high-strength chemical-cured hand-mixed GIC in the first visit itself .The restorative procedures will follow the guidelines of the ART approach , which are briefly described below:

  • The operation site will be isolated by cotton rolls
  • Adequate access to the cavity will be created, if necessary an enamel hatchet will be used to enlarge the opening of a small cavity.
  • Excavators of different sizes will be used to remove soft carious tissues and to prepare the cavity for restoration.
  • The cavity will be cleaned by water and then dried by cotton pellets.
  • The cavity surface will be conditioned with dentin conditioner (GC Gold Label, Japan) for 10 s, then washed with water and dried by cotton pellets.
  • The GIC (GC Gold label, Japan) will be mixed according to the manufacturer’s instructions;
  • The restorative material will be placed and pressed into the cavity by the ‘finger technique’, matrix will be used when placing GIC into a cavity in proximal tooth surface;
  • The excess GIC material will be removed;
  • The contour and shape of the restoration will be modified as necessary and the occlusion will be checked;
  • The finished restoration will be covered by a layer of petroleum jelly.

The children will be instructed not to eat or drink for half an hour.

The patient will be recalled after 2 weeks. In Group A, SDF treated cavity will be restored with the use of ART approach  using GIC (GC Gold Label, Japan).

The restorative procedures will follow the guidelines of the ART approach, as described for Group B.

ART evaluation criteria   is used for clinical evaluation of the restorations at baseline, 6 months and 12 months.

Radiograph will be taken after 12 months follow up.

Clinically the restorations will be evaluated based on following criteria using CPI Probe.

CODE

CRITERIA

DEFINITION

0

Present ,satisfactory.

Successful

1

Present ,slight defect in the cavity margin of less than 0.5 mm, no repair is needed

Successful

2

Present, marginal defect deeper than 0.5mm

Failed

3

Partially present , restoration and/or tooth breakdown.

Failed

4

Not present; restoration missing

Failed

5

Not present, other restorative treatment has been performed

Failed

6

Not present, tooth has been extracted

Failed

7

Pulpal involvement

Failed

C

Caries present

Failed

 

 
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