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CTRI Number  CTRI/2024/08/072965 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 17/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare and evaluate the various caries removal methods followed by the application of Silver Diamine Fluoride 
Scientific Title of Study   Comparative Evaluation of Selective Caries Removal Techniques Followed by SDF Application In Primary Molars - 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 Meenu Bhola 
Designation  Professor and Head 
Affiliation  Baba Farid University of health sciences, Faridkot 
Address  Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot

Faridkot
PUNJAB
151203
India 
Phone  9888023400  
Fax    
Email  meenubhola@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shreya 
Designation  Post-graduate Student 
Affiliation  Baba Farid University of health sciences, Faridkot 
Address  Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot

Faridkot
PUNJAB
151203
India 
Phone  9877380938  
Fax    
Email  dr.shreyagargg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreya 
Designation  Post-graduate Student 
Affiliation  Baba Farid University of health sciences, Faridkot 
Address  Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot

Faridkot
PUNJAB
151203
India 
Phone  9877380938  
Fax    
Email  dr.shreyagargg@gmail.com  
 
Source of Monetary or Material Support  
Dasmesh Institue of Research and Dental Sciences, Talwandi Road, Faridkot, Punjab, India pincode 151203 
 
Primary Sponsor  
Name  Dr Shreya 
Address  Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot, Punjab, India pincode 151203 
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 Shreya  Dasmesh Institue of Research and Dental Sciences, Talwandi Road, Faridkot  Department of Pediatric and Preventive Dentistry
Faridkot
PUNJAB 
9877380938

dr.shreyagargg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional review board  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 
Intervention  Caries removal using chemo-mechanical caries removing agent followed by SDF application and GIC restoration  The chemo-mechanical caries removing gel (Dengen Dental Carie Fix Caries Removing Gel) will be applied to the lesion. After 30 seconds (as per the manufacturer’s instructions), the gel will be removed using a moistened cotton pellet, and softened carious dentin will be removed using a spoon excavator. If necessary, a second application can be performed in areas where the caries are hard, to soften the caries for easier removal. Once again, the gel will be removed using a moistened cotton pellet and the remaining caries will be excavated using a spoon excavator. Caries excavation will be considered complete when no caries can be detected with tactile method. 
Comparator Agent  Caries removal using Hand Instruments followed by SDF application and GIC restoration  The affected tooth will be visually inspected or probed, to determine the extent of decay. Then, the caries will be excavated using a sharp spoon excavator in gentle scraping motions to scoop out the soft, decayed dentin. Caries excavation will be considered complete when no caries can be detected with tactile method 
Intervention  Caries removal using polymer bur followed by SDF application and GIC restoration  Caries will be excavated using polymer bur (SS White Smart Burs II). The polymer bur will be mounted on a low-speed contra-angled handpiece. Caries will be removed in a circular motion starting from the centre of the lesion towards the periphery. Caries removal will continue until polymer bur becomes dull after repeated contact with healthy dentin and becomes visibly abraded and blunt. Cutting will be done till no more softened dentin is present. Additional polymer burs can be used until caries are completely removed. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Children with written informed consent
2.Healthy children from 4 to 8 years of age
3.Cooperative child
4.Children with asymptomatic carious lesions in primary molars extending into the dentin (ICDAS score 4 OR 5)
5.Teeth that are restorable
6.No clinical evidence of pulpal degeneration (pain on percussion, history of swelling, sinus tract) 
 
ExclusionCriteria 
Details  1.Uncooperative children
2.Medically compromised patients
3.Teeth with a history of spontaneous pain or pulpal degeneration
4.Grossly decayed teeth
5.Teeth with radiographic signs of internal / external resorption or furcation involvement
6.Teeth near physiological exfoliation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To clinically and radiographically evaluate the efficacy of caries removal using hand instruments,chemo-mechanical caries removing agent, and smart burs followed by SDF application and GIC restoration in deep carious primary molars.
 
evaluation will be done immediately after procedure and at 1, 3, 6, and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
time taken to complete procedure  immediately after procedure 
pain perception by patient using Wong Baker FACES Pain Rating Scale  immediately after procedure 
Score for Caries Excavation based on Ericson D et al. Criteria (1999)  at baseline 
clinical evaluation : pain (on percussion), fistula, sinus opening & pathological mobility  at baseline, 1 month, 3 months, 6 months & 9 months
 
radiogarphic evaluation for pathologica root resorption, normal periodontal ligament space & absence of periapical and/or bifurcation radiolucency  at baseline, 1 month, 3 months, 6 months & 9 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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/ 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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 04-01-2025 and end date provided 04-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Preoperative clinical and radiographic examinations will be done to ensure proper case selection. The involved tooth will be isolated with cotton rolls and a saliva ejector. The working time will be calculated from the beginning of caries excavation in all three groups, using a stopwatch. GROUP I (Caries removal using Hand Instruments followed by SDF application): The affected tooth will be visually inspected or probed, to determine the extent of decay. Then, the caries will be excavated using a sharp spoon excavator in gentle scraping motions to scoop out the soft, decayed dentin. Caries excavation will be considered complete when no caries can be detected with tactile method. GROUP II (Caries removal using chemo-mechanical caries removing agent followed by SDF application): The chemo-mechanical caries removing gel (Dengen Dental Carie Fix Caries
Removing Gel) will be applied to the lesion. After 30 seconds (as per the manufacturer’s instructions), the gel will be removed using a moistened cotton pellet, and softened carious dentin will be removed using a spoon excavator. If necessary, a second application can be performed in areas where the caries are hard, to soften the caries for easier removal. Once again, the gel will be removed using a moistened cotton pellet and the remaining caries will be excavated using a spoon excavator. Caries excavation will be considered complete when no caries can be detected with tactile method. GROUP III (Caries removal using polymer bur followed by SDF application): Caries will be excavated using polymer bur (SS White Smart Burs II). The polymer bur will be mounted on a low-speed contra-angled handpiece. Caries will be removed in a circular motion starting from the centre of the lesion towards the periphery. Caries removal will continue until polymer bur becomes dull after repeated contact with healthy dentin and becomes visibly abraded and blunt. Cutting will be done till no more softened dentin is present. Additional polymer burs can be used until caries are completely removed. Caries excavation will be evaluated using Ericson D et al. scale (1999). Caries excavation will be followed by the application of 38% Silver Diamine Fluoride solution (FAgamin). It will allow the removal of gross debris, allowing SDF to be in maximum contact with the affected dentin surface. Before the application of SDF, a protective coating of petroleum jelly will be applied to surrounding soft tissues to avoid their discoloration. One drop of SDF will be placed in a plastic dappen dish and will be applied to the excavated area with an applicator tip for 1 minute, using a gentle flow of compressed air until the liquid is dry. The remaining tooth structure will be restored with GC Gold Label Universal Restorative Cement. Time taken in caries excavation followed by SDF application during each procedure will be compared. Patient acceptance will be assessed using the Wong-Baker Faces Pain Scale which can easily be understood by
children as it consists of a series of faces depicting different levels of pain, ranging from a smiling face representing “no hurt” with a score of 0 and to a crying face indicating “hurts worst” with a score of 10. After the completion of the treatment, patients will be recalled after 1, 3, 6, and 9 months. Clinical and radiographic outcomes of the procedure will be recorded during each visit.
 
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