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CTRI Number  CTRI/2025/06/089838 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 28/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Efficacy of Theracal PT and Biodentine Materials on Two Different Vital Pulp Therapies in Children 
Scientific Title of Study   Comparative Evaluation of Theracal PT and Biodentine for Two Different Vital Pulp Therapies 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  Vedashree Chaudhari 
Designation  Post Graduate Student 
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Pune
MAHARASHTRA
411008
India 
Phone  7767813199  
Fax    
Email  vedashree1398@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Lalit Patil  
Designation  Associate Professor  
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Pune
MAHARASHTRA
411018
India 
Phone  9765370827  
Fax    
Email  drlalitpatil47@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Lalit Patil  
Designation  Associate Professor  
Affiliation  Dr. D.Y. Patil Dental College and Hospital, Pimpri, Pune 
Address  Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018
Pune
MAHARASHTRA
411018
India 
Phone  9765370827  
Fax    
Email  drlalitpatil47@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil Dental College, Sant Tukaram Nagar, Pimpri, Pune - 411018 
 
Primary Sponsor  
Name  Vedashree Chaudhari 
Address  F2-004, Success Towers, State Bank Nagar, Panchavati, Pashan Road, Pune - 411008 
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 Lalit Patil  Dr. D. Y Patil Dental College and Hospital, Pimpri, Pune  Department Number 8, Second Floor, Department of Pediatric and Preventive Dentistry, Pune, Maharashtra
Pune
MAHARASHTRA 
9765370827

drlalitpatil47@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D.Y. Patil Dental College and Hospital Institutional Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children aged 4-7 years, with dental caries 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Biodentine  the investigational product is Biodentine. It is a highly pure tricalcium silicate material. When it comes into direct contact with a vital pulp, it stimulates pulp cells and encourages the development of reparative dentin. Its clinical effectiveness will be assessed at 1 month and 6 month post operatively. 
Intervention  Theracal PT  The investigational product is Theracal PT. It is a dual-cure calcium silicate material enhanced with resin, was recently introduced to the market for vital pulp therapy. Theracal PT has certain properties such as cytocompatibility and biocompatibility. Its clinical effectiveness will be assessed at 1 month and 6 month post operatively  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Children between 4-7 years of age.
Participants parents who give consent to participate in the study.
Atleast 1 restorable primary mandibular 2nd molar with caries extending in dentin without pulpal approachment.
Caries involving one-third of dentin on radiographic examination
Atleast 1 restorable primary mandibular 2nd molar with deep occlusal caries indicated for pulpotomy.
Vital tooth with healthy periodontium.
Caries involving coronal portion of pulp on radiographic examination.

 
 
ExclusionCriteria 
Details  Spontaneous or nocturnal pain and Pain on pressure.
Intraoral swelling and Sinus tract.
Pathological mobility or Furcation involvement.
Peri-radicular radiolucency and Internal or external root resorption.
Widening of periodontal ligament and Discontinuity of lamina dura.
Patients with any systemic diseases.
Children with special health care needs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare Theracal PT and Biodentine for Indirect Pulp Capping on the basis of clinical and radiographic parameters.
To evaluate and compare Theracal PT and Biodentine for Pulpotomy on the basis of clinical and radiographic parameters.
 
18 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
Success rate & effectiveness of the materials used at different point intervals  1 month
6 months 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   15/07/2025 
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  

Need for the study

Caries is defined as the process of enamel or dentin dissolution that is caused by microbial action at the tooth surface as is mediated by physiochemical flow of water dissolved ions (Ostrom,1980).Vital pulp therapy is a conservative treatment modality that seeks to preserve the vitality and functionality of the dental pulp that has been exposed due to caries or trauma. Indirect Pulp Capping is a single step procedure that entails the Selective Caries Removal (SCR) of heavily infected superficial necrotic dentin while the affected firm dentin is left over the pulp. Pulpotomy can be defined as the complete removal of coronal portion of the dental pulp, followed by placement of suitable dressing or medicament that will promote healing and preserve the vitality of tooth (Finn, 1959). Bisco has recently launched a new dual cured resin-modified calcium silicate-based (Theracal PT). Its primary indication is pulpotomy since it can be used in adequate thickness. It can also be utilized as a direct and indirect pulp capping material as a base under various substrates. Biodentine has been introduced and progressed (through the biosilicate technology ) with the purpose of incorporating the increased biocompatibility and the bioactivity of calcium silicates, producing improved features that cause it to be better than any other calcium silicate–based cements. Thus, the aim of the study is intended to comparatively evaluate Theracal PT (Bisco, America) and Biodentine (Septodont, France) for two different vital pulp therapies in primary molars.

 

 

Aim of the study: 

To evaluate and compare Theracal PT and Biodentine for two different vital pulp therapies in primary molars.

 

 

Objectives of the study:

 

1.     To evaluate and compare Theracal PT (Bisco, America) and Biodentine (Septodont, France) for Indirect Pulp Capping on the basis of clinical and radiographic parameters.

2.     To evaluate and compare Theracal PT (Bisco, America) and Biodentine (Septodont, France) for Pulpotomy on the basis of clinical and radiographic parameters.

 

Source of data

 Type of study – Comparative study

             In-vitro/in-vivo/survey – in – vivo study

          Source from where the cases, patients, subjects, or study material will be selected-

Dept Of Pediatric and Preventive Dentistry, Dr. D. Y Patil Dental College and Hospital, Pimpri, Pune.

         Name and place where the study will be conducted-

         Dept Of Pediatric and Preventive Dentistry, Dr. D. Y Patil Dental College and Hospital,    Pimpri, Pune

 

Method of data collection

Sampling technique used – Convenience sampling

Sample size – 144

Size of each group: 36

Group I: Indirect Pulp Capping using Theracal PT (Bisco, America)

Group II: Indirect Pulp Capping using Biodentine (Septodont, France)

Group III: Pulpotomy using Theracal PT (Bisco, America)

Group IV: Pulpotomy using Biodentine (Septodont, France)

 

Inclusion criteria:

1.     Children between 4-7 years of age.

2.     Participants parents who give consent to participate in the study.

3.     Atleast 1 restorable primary mandibular 2nd molar with caries extending in dentin without pulpal approachment.

 

4.     Caries involving one-third of dentin on radiographic examination

 

5.     Atleast 1 restorable primary mandibular 2nd molar with deep occlusal caries indicated for pulpotomy.

 

6.     Vital tooth with healthy periodontium.

 

7.     Caries involving coronal portion of pulp on radiographic examination.

 

Exclusion criteria:

1.     Spontaneous or nocturnal pain and Pain on pressure.

2.     Intraoral swelling and Sinus tract.

3.     Pathological mobility or Furcation involvement.

4.     Peri-radicular radiolucency and Internal or external root resorption.

5.     Widening of periodontal ligament and Discontinuity of lamina dura.

6.     Patients with any systemic diseases.

7.     Children with special health care needs.

 

 

MATERIALS:

 

Theracal PT (Bisco)

Biodentine (Septodont)

Rubber dam (Coltene)

Glass Ionomer Cement (GC)

Local anaesthesia (2% lignocaine with 1:200000 adrenaline, NEON)

0.12% Chlorhexidine Gluconate (AMMDENT)

 

 

 

INSTRUMENTS:

 

Diagnostic instruments

Spoon excavator

GIC Mixing Pad

Agate spatula

 

 

ARMAMENTERIUM :

 

Mouth mask, Head cap

Gloves

 

Procedure:

Patients will be selected according to the inclusion and exclusion criteria. The study procedure will be explained to each participant’s parents and necessary informed consent from the parent/guardian and assent from the child will obtained in a language they understand. Teeth will be isolated using rubber dam after administration of local anaesthesia. Patients will be divided into four groups. Group 1: Indirect Pulp Capping using Theracal PT

N = 36  Group 2: Indirect Pulp Capping using Biodentine N = 36  Group 3: Pulpotomy using Theracal PT N = 36  Group 4: Pulpotomy using Biodentine N = 36

For Indirect Pulp Capping, Caries will be removed with slow speed round bur. Peripheral caries will be removed with spoon excavator, if any. Theracal PT will be applied in 2mm thickness and light cured for 10 sec as per manufacturer instructions followed by GIC restoration. Biodentine will applied in 2mm thickness as per manufacturer instructions followed by GIC restoration.

For Pulpotomy, Caries will be removed with slow speed round bur before pulp exposure. Once pulp will be exposed, roof of the pulp chamber will be removed using no. 330 carbide bur. Spoon excavator to be used to remove pulp remnants adhering to pulp floor.

Theracal PT will be applied in 2mm thickness and light cured for 10 sec as per manufacturer instructions followed by GIC restoration. Biodentine will applied in 2mm thickness as per manufacturer instructions followed by GIC restoration.

Follow up for clinical and radiographic evaluation will be done at 1 and 6 months.

Data will be recorded and tabulated and results will be analyzed using statistical analysis method.

 

 

Method of data analysis

McNemar test

Cox regression for survival

 
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