| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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.
|
|
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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. |