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CTRI Number  CTRI/2025/01/079343 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Success Rates of Two Dental Materials for Protecting Exposed Pulps in Adult Molars 
Scientific Title of Study   Outcome of direct pulp capping With Premixed Bioceramic Material And Mineral Trioxide Aggregate In Mature Permanent Molars With Pulps Exposed During Carious Tissue Removal: A Randomized Clinical 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 Sachin Sunil Sawant 
Designation  Post Graduate Student 
Affiliation  Kaher KLE VIshwanath Katti Institute Of Dental Sciences 
Address  Department No 7 2nd Floor Department of Conservative Dentistry and Endodontics Kaher Institute Of Dental Sciences JNMC Campus Nehru Nagar Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8308549132  
Fax    
Email  sachinsawant1411@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sachin Sunil Sawant 
Designation  Post Graduate Student 
Affiliation  Kaher KLE VIshwanath Katti Institute Of Dental Sciences 
Address  Department of Conservative Dentistry and Endodontics Department No. 7, 2nd Floor, KAHER KLE Vishwanath Katti Institiute of Dental Sciences, Belagavi, Karnataka 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8308549132  
Fax    
Email  sachinsawant1411@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonal B Joshi 
Designation  Professor and Dean 
Affiliation  Kaher KLE VIshwanath Katti Institute Of Dental Sciences 
Address  Department No 7 2nd Floor Department of Conservative Dentistry and Endodontics Kaher KLE Vishwanath Katti Institute Of Dental Sciences JNMC Campus Belgaum Karnataka 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9448141278  
Fax    
Email  jsonal70@yahoo.co.in  
 
Source of Monetary or Material Support  
Kaher KLE Vishwanath Katti Institute Of Dental Sciences JNMC Campus Nehru Nagar Belgaum KARNATAKA 590010 India 
 
Primary Sponsor  
Name  Dr Sachin Sunil Sawant 
Address  Department NO 7 2nd Floor Department of Conservative Dentistry and Endodontics KAHER KLE Vishwanath Katti Institute Of Dental Sciences JNMC Campus Nehru Nagar Belgaum Belgaum Karnataka 590010 India 
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 Sachin Sunil Sawant  Kaher KLE Vishwanath Katti Institute of Dental Sciences, Belagavi, Karnataka- 590010  Department No.7 2nd Floor Department Of Conservative Dentistry And Endodontics Kaher KLE Vishwanath Katti Institute Of Dental Sciences JNMC Campus Nehru Nagar Belgaum Belgaum Karnataka 590010 India
Belgaum
KARNATAKA 
8308549132

sachinsawant1411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pulp Capping using Mineral Trioxide Aggregate  The exposed pulp will be gently pressed with a cotton pellet soaked in 3% sodium hypochlorite. 2-3mm layer of Mineral Trioxide Aggregate will be placed according to manufacturers instructions followed by placement of Resin Modified Glass Ionomer Cement and Permanant Bulk Fill Composite Restoration on the same day. The patient will be assessed for a period of 6 month duration 
Intervention  Pulp capping using Premixed Bioceramic Material  The exposed pulp will be gently pressed with a cotton pellet soaked in 3% sodium hypochlorite. 2-3mm layer of Premixed Bioceramic Material will be placed as per the manufacturers instructions followed by placement of Resin Modified Glass Ionomer Cement and Permanant Bulk Fill Composite Restoration on the same day. The patient will be assessed for a period of 6 month duration  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Pre-Caries Excavation inclusion criteria
A Permanent maxillary and mandibular first and second molars with large carious lesions involving either occlusal or proximal surfaces
B Radiographic examination revealing carious lesions in close proximity to the pulp
C Teeth with history of pain of short duration, caused by a specific irritant and disappearing when irritant is removed
D Patients with non-contributory medical history, good general health
E Patients ranging in the age group of 16-40 years
F Teeth with adequate coronal structure to ascertain proper isolation

Post-Caries excavation inclusion criteria
1 Pulp Exposures less than 1mm
2 Teeth which achieved haemostasis within 10 minutes
3 Non contaminated operating field 
 
ExclusionCriteria 
Details  A. PATIENT SPECIFIC
1. Patients who refuse to consent for the procedure
2. Patients with any systemic diseases, pregnancy or immuno-compromised conditions
3. Patients allergic to lignocaine or any other material used in the trial

B SPECIFIC TO DIAGNOSIS
1. Teeth presenting a negative cold thermal test and a prolonged or no response to electric pulp testing
2. Teeth with symptoms and signs of irreversible pulpitis
3. Teeth exhibiting periapical radiolucencies on radiographic examination
4. Teeth exhibiting rarefying or condensing osteitis on radiographic examination
5. Teeth with internal or external resorption
6. Teeth showing positive responses to percussion or palpation
7. Retreatment cases
8. Teeth with aggressive periodontitis or mobility

TOOTH SPECIFIC
1 Teeth showing persistent pulpal hemorrhage after receiving 10 minutes of sodium hypochlorite dressing during the pulp capping procedure
2 Teeth with greater than1mm of pulpal exposure
3 Teeth which have been managed by Indirect Pulp Capping Procedure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the treatment outcome of direct pulp capping using Premixed bioceramic material or Mineral Trioxide Aggregate clinically and radiographically at 1 week, 3 months and 6 months  1 week, 3 months and 6 months intervals.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the association of variables namely age, sex and caries location between the groups.
 
1 week, 3 months and 6 months intervals.  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   02/02/2025 
Date of Study Completion (India) 23/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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  

In our day-to-day clinical practice most of the patients walk into our clinic with deep or extremely deep carious lesions. To ensure a line of treatment which has always been successful, dentists intervene by doing root canal treatment because of its high success rate. However after delivery of root canal treatment the vitality of the pulp is lost. The vitality of the pulp is essential to Preserve the defense mechanism of the pulp Enable dentin formation, Enhancement of the Survival rate- Vital Teeth > Endodontically treated teeth, Avoid root fracture. Because of this, we are mindful in excavating, deep, extremely deep carious lesions, because today there is a concept of selective caries excavation which advices removal of infected dentine and keeping the affected dentine in place and packing it with pulp capping material which is known as Indirect Pulp Capping. However, AAE , very firmly in there position statement have said hard or firm dentin and dentin below white spot enamel lesions is infected by bacteria in both active and arrested lesionsHistobacteriological studies have consistently shown the presence of chronic inflammatory cell infiltrates and subclinical pulp inflammation where carious tissues are retained, thus potentially compromising pulp vitality. Keeping this school of thought in effect, when caries are very deep we may adverently expose the pulp during the removal of caries itself. We have a Position Statement by our very own Indian Endodontic Society published in the year 2022 which states that Direct Pulp Capping(DPC) is considered the most conservative and simplest of the VITAL PULP THERAPIES. It involves applying a biomaterial directly onto the exposed pulp before immediately placing a permanent restoration under aseptic conditions. A randomized clinical trial provides the highest level of support for evidence based clinical practice. There have not been many randomized clinical trials conducted for comparing the outcomes of Premixed Bioceramic Material and Mineral Trioxide Aggregate in mature permanent molars with pulps exposed during carious tissue removal. As DPC is mostly a onevisit procedure, conservative, costeffective, preserving pulp vitality, immunological and proprioceptive function of dental pulp while delaying the restorative cycle, and is considered an ideal treatment option for India where the oral disease burden is high. Thus, there is a need for a randomized clinical trial to evaluate and compare the Treatment outcome of Direct Pulp Capping using the new Premixed Bioceramic Material and comparing it with Mineral Trioxide Aggregate which is advocated for direct pulp capping procedures today.

 
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