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CTRI Number  CTRI/2025/12/098862 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Comparative Study of Papacarie, V-Carie-Solve, and Conventional Methods for Caries Removal in Primary Molars 
Scientific Title of Study   COMPARATIVE EVALUATION OF THE EFFICACY, TIME TAKEN AND PAIN PERCEPTION OF PAPACARIE, V-CARIE-SOLVE AND CONVENTIONAL HAND INSTRUMENTATION FOR CARIES REMOVAL IN PRIMARY MOLARS: A RANDOMIZED CONTROLLED TRIAL 
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 Neha Battulwar 
Designation  Postgraduate Student 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Nagpur 
Address  Second Floor,202,Department of Pediatric and Preventive Dentistry, Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Nagpur Wanadongri,Hingna
Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Nagpur Wanadongri,Hingna
Nagpur
MAHARASHTRA
441110
India 
Phone  9021090194  
Fax    
Email  nehabattulwar16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MILIND WASNIK 
Designation  Associate Professor 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital ,Nagpur 
Address  Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Nagpur
Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Nagpur
Nagpur
MAHARASHTRA
441110
India 
Phone  9975050807  
Fax    
Email  milind.wasnik@sdk-dentalcollge.edu.in  
 
Details of Contact Person
Public Query
 
Name  DR MILIND WASNIK 
Designation  READER 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital ,Nagpur 
Address  Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Nagpur
Wanadongri,Hingna
Nagpur
MAHARASHTRA
441110
India 
Phone  9975050807  
Fax    
Email  milind.wasnik@sdk-dentalcollge.edu.in  
 
Source of Monetary or Material Support  
Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Wanadongri,Hingna, Nagpur-441110 
 
Primary Sponsor  
Name  Dr. Neha Battulwar 
Address  Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Wanadongri,Hingna, Nagpur-441110 
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 Neha Battulwar  Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital,  Second Floor,202, Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital, Wanadongri,Hingna, Nagpur-441110
Nagpur
MAHARASHTRA 
9021090194

nehabattulwar16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional hand instrumentation  Conventional caries removal by hand excavation uses manual instruments (spoon excavator) to remove softened/infected dentin by tactile excavation.  
Intervention  Papacarie  Papacarie is a papain-based gel. Its main active component is papain (a proteolytic enzyme from papaya) combined with chloramine (an antiseptic/softening agent), a thickening vehicle, preservatives and a dye (toluidine blue) in an aqueous gel. Papain degrades denatured collagen in infected dentin, selectively softening necrotic/infected dentin while leaving sound dentin relatively unaffected. Chloramine contributes antimicrobial/disinfectant action and further softening. 
Comparator Agent  V-Carie-Solve  V-Carie-Solve is a commercially available papain/papaya-extract gel marketed as a CMCR agent. Typical formulation information from product literature lists papaya extract (rich in papain), chloramine, clove oil (therapeutic/analgesic/anti-inflammatory adjunct), preservatives and a gel vehicle. The papain fraction acts by selectively degrading infected/denatured collagen and softening carious dentin for hand excavation 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Children aged 4–9 years.
2. Broad cavitated occlusal lesion with dentinal involvement and occlusal access (ICDAS Score 5 or 6 and should be 3 x 4 mm in dimension).
3. Radiograph showing dentinal caries not involving pulp.
4. The consistency of carious lesions ranges from soft to medium hard.
5. Color ranges from light yellow to brown.
6. Patients exhibiting Frankl’s Behaviour Rating Scale score of 3 and 4.
 
 
ExclusionCriteria 
Details  1. Cases requiring restorative treatment that is not of the Class I variety.
2. Teeth with history of spontaneous or nocturnal pain
3. Extensively damaged teeth.
4. Radiograph showing caries involving pulp.
5. Medically or developmentally compromising conditions.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the clinical efficacy,microbial efficacy, time taken and pain perception of Papacarie, V-Carie-Solve and Conventional Hand Instrumentation for caries removal in primary molars.
 
At Baseline and immediately postop
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the clinical & microbial efficacy, time taken & pain perception of Papacarie, V-Carie-Solve & Conventional Hand Instrumentation for caries removal in primary molars.   12 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   N/A 
Date of First Enrollment (India)   18/01/2026 
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)  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 - NO
Brief Summary  

This randomized controlled trial aims to compare the clinical efficacy, microbial efficacy, time taken, and pain perception associated with three different caries-removal techniques—Papacarie, V-Carie-Solve, and conventional hand instrumentation—in primary molars of children aged 4–9 years. Sixty-six carious primary molars meeting strict inclusion criteria (ICDAS 5 or 6 lesions, radiographic dentinal involvement without pulpal extension, Frankl 3 or 4 behaviour) will be randomly assigned into three equal groups of 22 teeth each.

In Group I, caries removal will be performed using the papain-based chemomechanical gel Papacarie, applied for 30–40 seconds followed by gentle excavation. Group II will undergo a similar protocol using V-Carie-Solve, a newer papain- and clove-oil–based gel. Group III, the control group, will receive caries removal solely through conventional hand instrumentation using a spoon excavator.

Before and after excavation, dentinal samples will be collected and transported in Brain Heart Infusion Broth for microbiological analysis, with colony-forming units quantified using blood agar plating under anaerobic incubation. Clinical efficacy will be assessed through visual and tactile criteria using the Ericson 0–5 scoring system. Time taken for complete excavation will be recorded using a stopwatch, while pain perception will be evaluated using both subjective (Wong-Baker FACES) and objective (FLACC) scales during and after the procedure. Final restorations will be placed using glass ionomer cement.

The study seeks to determine whether chemomechanical agents offer superior comfort, reduced microbial load, and acceptable clinical performance compared to conventional hand excavation, ultimately contributing to minimally invasive and child-friendly dentistry.


 
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