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CTRI Number  CTRI/2021/12/038816 [Registered on: 21/12/2021] Trial Registered Prospectively
Last Modified On: 31/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to assess the effectiveness of a silver and fluoride containing re-mineralizing agent on arresting the progression of tooth decay. 
Scientific Title of Study   Effectiveness of 38% silver diamine fluoride application along with atraumatic restorative treatment on cavitated carious lesion of permanent teeth in adults compared to atraumatic restorative treatment - A randomized controlled trial. 
Trial Acronym  SD-ART  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anju Varughese 
Designation  PhD Scholar 
Affiliation  Amrita School of Dentistry 
Address  Department of Conservative Dentistry and Endodontics, AIMS, Ponekkara P.O.

Ernakulam
KERALA
682041
India 
Phone  7907431129  
Fax    
Email  ann.wez0306@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Chandrashekar Janakiram 
Designation  Professor 
Affiliation  Amrita School of Dentistry 
Address  Department of Public Health Dentistry, AIMS, Ponekkara P.O.
Ponekkara, AIMS PO
Ernakulam
KERALA
682041
India 
Phone  9446227870  
Fax    
Email  sekarcandra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Chandrashekar Janakiram 
Designation  Professor 
Affiliation  Amrita School of Dentistry 
Address  Department of Public Health Dentistry, AIMS, Ponekkara P.O.
Ponekkara, AIMS PO
Ernakulam
KERALA
682041
India 
Phone  9446227870  
Fax    
Email  sekarcandra@gmail.com  
 
Source of Monetary or Material Support  
Kids-e-dental LLP, Mumbai, India 
 
Primary Sponsor  
Name  Amrita School of dentistry  
Address  AIMS, Ponekkara P.O 682041, Kochi, Kerala  
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 
Anju Varughese  Amrita School of Dentistry  Department of Conservative Dentistry and Endodontics, Room No: 9, III floor, AIMS, Ponekkara P.O. Kochi 682041
Ernakulam
KERALA 		 7907431129

ann.wez0306@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Amrita Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, (2) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Atraumatic restorative treatment   Placement of ART restoration The preparation of the cavity will be done as stated above using hand instruments. Conditioning of the prepared tooth surface will be done with an applicator tip saturated with the polyacrylic acid liquid for 10 -15 seconds. Glass Ionomer Cement (GIC Fuji IX) will be prepared according to the manufacturer’s instructions and placed into the cavity using a plastic filling instrument. The press finger technique will be followed, and the surface of the restoration will be coated with petroleum jelly. The bite will be checked using articulation paper and the occlusal adjustments will be done. A digital radiograph of the restored tooth will be taken after the procedure. This radiograph will be compared with the one taken at the end of the 6th months of the follow-up visits for the assessment of caries arrest.  
Intervention  Silver diamine fluoride and Atraumatic restorative treatment   The caries lesion entrance will be widened and with help of a dental hatchet the thin unsupported frangible enamel will be removed. In the next step the decayed tissue will be excavated with a spoon excavator, first at dentin enamel junction and thereafter from cavity walls and pulpal floor. The cavity will then be washed with water and air-dried followed by isolation with cotton rolls. Application of Silver Diamine Fluoride Using a disposable micro applicator tip, the SDF will be applied to the walls of the prepared cavity, for duration of 10 seconds and would be allowed to air dry for one minute. A drop of 38% SDF solution (2.24 F-ion mg/dose) would be required per tooth. A saturated solution of Potassium Iodide (SSKI) will be applied with a different micro sponge to decrease colour change and will be repeated 1-3 times until no further black discoloration is observed. Placement of ART restoration Glass Ionomer Cement (GIC Fuji IX) will be prepared according to the manufacturer’s instructions. The restorative material will be placed into the prepared cavity using a plastic filling instrument. The press finger technique will be used for approximately one minute and the restoration will be coated with petroleum jelly. A carver would be used to remove the excess material. Height of restoration will be adjusted after the bite is checked using articulation paper. A digital radiograph of the restored tooth will be taken after the procedure. This radiograph will be compared with the one taken at the end of the 6th month of the follow-up visit for the assessment of caries arrest.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or Female individuals, between the age of 18 to 65 years, with either one of these caries: Class 1 Caries (only occlusal surface involved in posterior teeth) or Class 2 Caries (occlusal and proximal surface of posterior teeth), without involving the pulp.
2. Patients understand the significance of SDF and ART treatment to prevent tooth decay.
3. Patients are willing to attend the follow up visits as required for the trial.
4. The Patient will be enrolled irrespective of special needs if the subject is willing and able to comply with all the trial requirements.
5. Patients with absence of periodontal disease.
 
 
ExclusionCriteria 
Details  1. Patient with stomatitis or ulcerative gingivitis.
2. Developmental abnormalities of enamel and dentin.
3. Serious non-communicable medical conditions including cardiac failure, poor glycaemic control.
4. Cavitated teeth missing greater than a third of the coronal tooth structure or having pulpal involvement. The pulp exposed tooth, obvious discoloration, premature hypermobility, and presence of a periapical abscess or a sinus, will be regarded as a tooth with pulpal involvement.
5. Known silver allergy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The objective of the clinical trial is to compare the effect of application of 38% SDF along with atraumatic restorative treatment against atraumatic restorative treatment alone in arresting active occlusal carious lesions on permanent teeth. It also intends to compare the survival of the restoration.   7th day, 30th day and 180th day 
 
Secondary Outcome  
Outcome  TimePoints 
patient satisfaction, and acceptability of the application of the SDF.  7th day, 30th day and 180th day 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   01/01/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   The protocol of the clinical trial is planned to be published. A full report of the study will also be published upon completion 
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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ann.wez0306@gmail.com].

  6. For how long will this data be available start date provided 02-12-2024 and end date provided 01-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

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

A randomized controlled trial with parallel design was adopted to compare the effectiveness of application of 38% silver diamine fluoride with atraumatic restorative treatment in cavitated permanent teeth to atraumatic restorative treatment. The study population consist of 220 adult patients from Dental college between the age group of 18 to 65 years. Each participant will be randomly allocated to either the intervention group or the control group on a computer based random generation method. The intervention arm includes the application of 38% SDF along with ART. The statistical analysis will be done using chi-squared test and Kaplan-Meier survival analysis will be conducted on the censored data for survival of the restoration.

 
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