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CTRI Number  CTRI/2025/08/093432 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative evaluation of MTA, Biodentine and TheraCal LC in vital pulp therapy of permanent molars with symptomatic pulpitis: An In Vivo Study 
Scientific Title of Study   Comparative Evaluation of Mineral Trioxide Aggregate, Biodentine and TheraCal LC In Vital Pulp Therapy In Management Of Permanent Molars With Symptomatic Pulpitis: 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 Prashant Srivastava 
Designation  Post-graduate student 
Affiliation  HKES S.NIjalingappa Institute of Dental Sciences and Research 
Address  HKES S.NIjalingappa Institute of Dental Sciences and Research,Sedam road,Rajapur Colony,Kalaburagi (Gulbarga)

Gulbarga
KARNATAKA
585105
India 
Phone  8660375164  
Fax    
Email  drprincemra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ratnakar P 
Designation  Professor 
Affiliation  HKES S.NIjalingappa Institute of Dental Sciences and Research 
Address  Dept. of Conservative Dentistry & Endodontics HKES S.Nijalingappa Institute of Dental Sciences and Research,Sedam road,Rajapur Colony,Kalaburagi (Gulbarga)

Gulbarga
KARNATAKA
585105
India 
Phone  9866599960  
Fax    
Email  dr.ratnakarchoudary@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prashant Srivastava 
Designation  Post-graduate student 
Affiliation  HKES S.Nijalingappa Institute of Dental Sciences and Research 
Address  Dept. of Conservative Dentistry & Endodontics HKES S.Nijalingappa Institute of Dental Sciences and Research,Sedam road,Rajapur Colony,Kalaburagi (Gulbarga)

Gulbarga
KARNATAKA
585105
India 
Phone  8660375164  
Fax    
Email  drprincemra@gmail.com  
 
Source of Monetary or Material Support  
HKES S.Nijalingappa Institute of Dental Sciences and Research, Kalaburagi 
 
Primary Sponsor  
Name  Dr. Prashant Srivastava 
Address  HKES S.Nijalingappa Institute of Dental Sciences and Research, Sedam Road, Kalauragi, Karnataka-585105 
Type of Sponsor  Other [Individual (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 Prashant Srivastava  HKESs S Nijalingappa Institute of Dental Sciences and Research Kalaburagi  Room number 4 Department of Conservative Dentistry and Endodontics
Gulbarga
KARNATAKA 
8660375164

drprincemra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S Nijalingappa Institute of Dental Sciences and Research Institutional Ethics Committee  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  Progression of Caries  Permanent Molars with Symptomatic Pulpitis will be intervened as per the status of pulp involvement for 6 months 
Comparator Agent  Vital Pulp Therapy Agent  MTA, Biodentine, Theracal LC for 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Systemically healthy patients (Category: ASA 1) aged between 18-50 years diagnosed with symptomatic or asymptomatic reversible or irreversible pulpitis on a permanent molar teeth.
2.Caries extending to inner dentin(3rd or quarter)
3.Periodontially healthy patient
4.Tooth without clinical/radiographic sign of apical periodontitis.
5.The teeth that respond positively to electric pulp test as well as to cold tests
 
 
ExclusionCriteria 
Details  1.Teeth with crown/root fractures, acute or chronic apical abscess, compromised periodontium, and open apex will be excluded.
2.Teeth exhibiting signs and symptoms of chronic irritation such as swelling, mobility, sinus tract.
3.Radiographic evidence of pathologic root resorption, inter-radicular bone loss, calcification in canal and periapical cysts.
4.Teeth which will be observed to be non-vital on cavity preparation shall be excluded
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinically assessment of the efficacy of Vital Pulp therapy using MTA, Biodentine and Theracal LC will be assessed  1 month, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Determination and comparison of the degree of reparative dentine formation after receiving vital pulp therapy with diverse materials.  Determination and comparison of the degree of reparative dentine formation after 1 month, 3 months, 6 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   N/A 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2025 
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 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 - NO
Brief Summary  

·       Pulp vitality is an important aspect in determining a tooth’s long-term health and survival, as exposed vital pulp has an intrinsic capacity for healing. By eliminating contaminated tissue and promoting dentin bridge formation with a minimally invasive approach: Vital Pulp Therapy works to preserve and protect the pulpal vitality of a tooth that has undergone mutilating factors such as dental caries, trauma, and operative failure, especially when pulp inflammation is limited to the outermost layers and the deeper layers are healthy. Although root canal therapy is well recognized to produce reliable results, it leaves teeth prone to fracture, and it would be preferable to provide patients with an alternative minimal invasive approach. Hence the argument for vital pulp therapy is that radicular pulp tissue is healthy or capable of recovering after surgical amputation of the damaged or contaminated coronal pulp.1,2,3

·       Direct pulp capping, which includes applying a protective pulp capping material directly over the exposure location, is typically indicated in a recent exposure of pulp that is pinpoint-sized. Indirect pulp capping is a treatment in which non-mineralizable carious tissue is removed, leaving a thin layer of remaining sound dentin at the deepest site of the cavity to prevent pulp exposure and the caries affected dentin is capped with suitable biocompatible material. In contrast, pulpotomy is described as the partial removal of the pulp (coronal component) while keeping the radicular pulp intact after establishing adequate hemostasis and restoration done with biocompatible materials.4,5

Since diagnosis is a crucial component of treatment planning in endodontics, dental pulp testing is an important and indispensable diagnostic tool. Sensory nerves of different sizes are significantly affected by changes in intra-pulpal pressure; when pressure levels rise, larger diameter A-delta fibers are mostly blocked and smaller diameter C-fibers are activated. C-fibers may continue to function even if the pulp degenerates as a result of the underlying disease because they are more resistant to hypoxia. The most commonly used pulp sensibility tests are thermal and electrical tests that stimulate the pulpal nerves either by conducting an electrical current through the tooth, which causes the odontoblast processes to move and subsequently mechanically stimulate the pulpal nerves, or with dentinal fluid displacement at temperature variations.

·       Despite recent technological advancements in dental materials, like improved biocompatibility, regenerative dentin capacity, bioactivity, fast setting time and decreased solubility, there still remains a quest for the perfect vital pulp therapy agent. Furthermore, research is currently ongoing in order to achieve the greatest possible clinical and radiographic success in permanent dentitions and the demand for better medications has opened the door for more clinical investigations to explore the effectiveness rate of Vital Pulp Therapy (VPT) in teeth using various protocols.7,8

·       Mineral Trioxide Aggregate (MTA) is a calcium silicate-based cement, developed by Torabinejad  that has been extensively researched and reported to provide high success rates(~90%) of treatment outcomes in vital pulp therapy .It is composed of portland cement (75%), bismuth oxide (20%) and  gypsum (5%). Portland cement is a combination of tricalcium silicate, dicalcium silicate, tricalium aluminate & tetracalciumaluminoferrite. In comparison to calcium oxide, it has many advantages including a homogenous dentinal bridge formation with fewer tunnel defects, sustained calcium release, biocompatibility, sealing ability, long-term stability, low solubility, hygroscopic nature, excellent sealing ability, solubilization of bioactive proteins, and ability for tissue remineralization. Although MTA has a greater success rate, the disadvantages of this material, including its high cost, technique sensitivity, longer setting time, potential for tooth discoloration and inclusion of poisonous heavy metals, have led researchers to hunt for other materials. Yet numerous studies have used MTA as a gold standard medicament in vital pulp therapy.9,10

·       Biodentine, a bioactive dentine substitute, composed of Tricalcium Silicate(80%), with Zirconium oxide as a radio-opacifier, calcium carbonate(15%) as a filler and water as setting accelerator of Calcium Chloride. It has been reported to have superior mechanical properties like better color stability, easier handling and manipulation and fast setting time. Its major drawbacks are low radioopacity and difficulty in maintaining a specific consistency.9,10,11,12

Theracal LC (Bisco,USA) was introduced to address the lack of adhesion between the resins and calcium silicate based materials in final restorations. Theracal LC is a calcium silicate filled, light-cured liner which provides an insulative and protective layer for pulp-dentin complex. Theracal LC releases calcium which enhances development of hydroxyapatite which in turn forms dentine bridge. It has superior bonding capacity compared to composite and glass-ionomer cement with a significant  bioactivity.Additional research is required to estimate its efficacy over a longer period of time. The newly developed materials have the ability to stimulate the pulp progenitor cells in an improved manner and there is ever growing demand for new developments of bioactive materials for Vital pulp Therapy (VPT). However, their long term success in permanent teeth still needs to be supported by further research.

 

 There have been studies which have been conducted in- vitro and most of them are in primary dentition. However, there are quite limited In-Vivo studies and case reports which have been done on Permanent teeth to substantiate the effects of MTA, Biodentine and Theracal LC and compare their clinical efficacy and radiographical analysis in contrast with each other under different vital pulp therapy procedures.The purpose of this study is to provide comparison between these bioactive materials of choice in Vital Pulp Therapy in treatment of permanent teeth with symptomatic pulpitis.

 
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