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CTRI Number  CTRI/2024/12/077953 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A comparative clinical and radiological evaluation of pulp capping agents in permanent teeth with carious pulp exposure – an in-vivo study. 
Scientific Title of Study   A comparative clinical and radiological evaluation of biodentine, platelet-rich fibrin, and acemannan as direct pulp capping agent in permanent teeth with various pulp exposure – 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 Manoj M Dhavalagi 
Designation  Postgraduate student 
Affiliation  K V G Dental College and Hospital  
Address  Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kuringibhag Sullia

Dakshina Kannada
KARNATAKA
574327
India 
Phone  09606373963  
Fax    
Email  drmanojmdhavalagi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Moksha Nayak 
Designation  Principal and Professor 
Affiliation  K V G Dental College and Hospital  
Address  Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kuringibhag Sullia

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448026828  
Fax    
Email  moksha.nayak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manoj M Dhavalagi 
Designation  Postgraduate student 
Affiliation  K V G Dental College and Hospital  
Address  Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kuringibhag Sullia

Dakshina Kannada
KARNATAKA
574327
India 
Phone  09606373963  
Fax    
Email  drmanojmdhavalagi@gmail.com  
 
Source of Monetary or Material Support  
K V G Dental College and Hospital Kuringibhag Sullia Dakshina Kannada Karnataka 574327 
 
Primary Sponsor  
Name  Manoj M Dhavalagi 
Address  K V G Dental College and Hospital Kuringibhag Sullia Dakshina Kannada Karnataka 574327 
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 Manoj M Dhavalagi  K V G Dental College and Hospital  Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kuringibhag Sullia Dakshina Kannada Karnataka 574327
Dakshina Kannada
KARNATAKA 
09606373963

drmanojmdhavalagi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
K V G Dental College and Hospital  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  Acemannan  Acemannan Will be used as pulp capping agent once based on size of pulp exposure 
Intervention  BIODENTINE   BIODENTIN Will be used as pulp capping agent once based on size of pulp exposure  
Comparator Agent  Platelet Rich Fibrin (PRF)  PRF Will be used as pulp capping agent once based on size of pulp exposure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  • Patients willing to participate in the study.
• Both males and females will be included within the age group of 18-35 years.
• Posterior tooth with a deep carious lesion with no pain and swelling for the involved tooth.
• Any tooth positive response to vitality testing (electric pulp tests and cold test), the response should be comparable to the contralateral tooth.
• Tooth responding negative to percussion test.
• Tooth with carious pulpal exposure not larger than 2 mm in diameter with mild symptoms and normal periapical tissues (Periapical index score ≤2)
• The bleeding from exposed pulp which can be resolved within less than five minutes.
• Tooth which could be restored with composite, amalgam, and stainless stain crown (restorable tooth structure).
 
 
ExclusionCriteria 
Details  • Teeth with large caries exposure with symptoms
(Teeth associated with pain and presence of soft tissue swelling or abscess in relation to involved teeth.)
• Teeth with Uncontrolled bleeding during caries removal.
• Teeth with cracks and defects and traumatic pulp exposure.
• Presence of signs and symptoms of irreversible pulpitis and periapical pathologies.
• Teeth that cannot be isolated with a rubber dam.
• Teeth with low prognosis which includes abnormal mobility. (Miller’s classification grade II and grade III)
• Presence of pulp canal obliteration or calcification.
• Evidence of internal and external root resorption.
• Pregnant and lactating mothers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical and radiological outcomes of direct pulp capping using Biodentin, Platelet Rich Fibrin, and Acemannan in cariously exposed vital permanent teeth.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
•To evaluate the clinical and radiological outcome of direct pulp capping using Biodentine in cariously exposed vital permanent teeth.
•To evaluate the clinical and radiological outcome of direct pulp capping using Platelet Rich Fibrin in cariously exposed vital permanent teeth.
•To evaluate the clinical and radiological outcome of direct pulp capping using Acemannan in cariously exposed vital permanent teeth.
•To compare the above three groups.
 
6 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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   Phase 3 
Date of First Enrollment (India)   01/01/2025 
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="2"
Months="2"
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  

The current treatment strategies in endodontics are undergoing a paradigm shift towards minimal invasive biological procedures in relation to the management of deep caries and vital pulp exposure. The concept of vital pulp therapy first coined by Dr. Louis I. Grossman, serves as a cornerstone for modern endodontics with advances in biomaterial and regenerative techniques. Various materials like calcium hydroxide, Zinc Oxide Eugenol (ZOE) Cement, Theracal, Mineral Trioxide Aggregate, Biodentine, Glass Ionomer/Resin Modified Glass Ionomer have been tested for direct pulp capping of cariously exposed vital teeth.

Biodentine is an innovative cement made of tricalcium silicate with inherent bioactive characteristics. The antibacterial properties of Biodentine are attributed to its high pH, which is achieved by the action of hydroxyl ions on the surrounding tissue. A thin layer of coagulative necrosis forms between the vital pulp tissue and Biodentine because of the increase in pH. There has been considerable research performed on this material as a direct pulp capping agent since its launch in 2009.

A biological approach towards pulp capping is Platelet concentrates which promote differentiation of new odontoblasts by preserving remaining odontoblasts. Platelet-rich fibrin derived from blood is a second-generation platelet concentrate introduced by Choukroun in 2001. It contains a multitude of growth factors which is conducive to healing such as transforming growth factor β1, platelet-derived growth factor, and insulin-like growth factor. It exhibits varied properties such as cell migration, cell proliferation, cell attachment, and cell differentiation. Clinical studies have shown that Platelet Rich Fibrin promotes soft tissue and bone regeneration.

In dentistry, a wide range of herbal extracts like Baicalin, Propolis, Nigella stevia, Genipin, Acemannan, and Galla Chinensis Extract have been employed to deal with the flaws of conventional treatment for vital pulp therapy. Among all the herbal extracts, Acemannan is a natural polysaccharide with good biodegradability and biocompatibility. It is an extract from aloe vera and has a range of therapeutic uses in pulp capping mainly because it stimulates dentin regeneration via increased pulp cell proliferation, differentiation, growth factor expression, extracellular matrix synthesis, and mineral deposition. Pre-clinical and clinical evidence both favor the application of this herbal extract to help in the regeneration of dentin.

Biodentine has shown to have efficient physical and biological properties as a pulp-capping material with a success rate of 83.4% to 90.9%.However, due to its limited insufficient radiopacity and discoloration potential, alternative materials such as human blood extract and herbal extract have been developed and increasingly used for direct pulp capping procedures. Platelet concentrations have shown a higher volume of dentine bridge formation in vital pulp therapy for adult permanent teeth with reversible pulpitis with a radiographic success rate of 90%. A similar positive response was observed with  Acemannan in direct pulp capping procedures of young permanent teeth, with success rates of 72.73% to 77.8%. There is significant variation in the literature regarding the ideal follow-up time for direct pulp capping. The outcome measure, related to pain as shown in the literature is 1 week to 3 months. and for dentine bridge formation, it is 3 to 6 months. The present study evaluates the efficacy of Biodentine, Platelet Rich Fibrin, and Acemannan as direct pulp-capping agents in permanent teeth with carious pulp exposure over a period of 6 months.


 
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