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CTRI Number  CTRI/2025/04/085029 [Registered on: 17/04/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Compare and Evaluate Egg Shell powder, Gel that stops bleeding and healing paste as medicine for nerve of tooth in milk teeth in children. 
Scientific Title of Study   Comparative Evaluation of Egg Shell based Hydroxyapatite, Feracrylum Gel and Mineral Trioxide Aggregate as Pulpotomy agent in Primary Molars : A Three-Arm Randomised Controlled Clinical 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 Saloni Joshi 
Designation  Postgraduate Student 
Affiliation  Terna Dental College 
Address  Room no. 224, 2nd Floor, Department of Pediatric and Preventive Dentistry, Terna Dental college, opposite Railway Station, Sector 22, Nerul West, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  7219012514  
Fax    
Email  salonisjoshi13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saloni Joshi 
Designation  Postgraduate Student 
Affiliation  Terna Dental College 
Address  Room no. 224, 2nd Floor, Department of Pediatric and Preventive Dentistry, Terna Dental college, opposite Railway Station, Sector 22, Nerul West, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  7219012514  
Fax    
Email  salonisjoshi13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saloni Joshi 
Designation  Postgraduate Student 
Affiliation  Terna Dental College 
Address  Room no. 224, 2nd Floor, Department of Pediatric and Preventive Dentistry, Terna Dental college, opposite Railway Station, Sector 22, Nerul West, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  7219012514  
Fax    
Email  salonisjoshi13@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatric Dentistry, Terna Dental College 
 
Primary Sponsor  
Name  Terna Dental College 
Address  Room no. 224, 2nd Floor, Department of Pediatric and Preventive Dentistry, Terna Dental college, opposite Railway Station, Sector 22, Nerul West, Navi Mumbai, Maharashtra 400706 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Dr Saloni Joshi  Room no. 224, 2nd Floor, Department of Pediatric and Preventive Dentistry, Terna Dental college, opposite Railway Station, Sector 22, Nerul West, Navi Mumbai, Maharashtra 400706 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saloni Joshi  Department of Paediatric and Preventive Dentistry  Room no. 224, 2nd Floor, Department of Pediatric and Preventive Dentistry, Terna Dental college, opposite Railway Station, Sector 22, Nerul West, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 		 7219012514

salonisjoshi13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Dental College Institutional Ethics Committee  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 
Intervention  Egg Shell based Hydroxyapatite,   Eggshell hydroxyapatite (HA) is a bioceramic derived from calcined eggshells, primarily composed of calcium phosphate. It mimics natural bone mineral, offering excellent biocompatibility and osteoconductivity. Used in bone grafts, dental implants, and tissue engineering, it enhances biomaterial performance due to its bioactivity, mechanical strength, and similarity to human bone. 
Intervention  Feracrylum Gel  Feracrylum is a water-soluble, cationic homopolymer of acrylamide used as a topical hemostatic agent. It promotes clot formation by electrostatic interaction with negatively charged blood cells and plasma proteins. Feracrylum exhibits antimicrobial properties, aiding wound healing. It is commonly used for bleeding control in surgical, dental, and trauma settings. 
Comparator Agent  Mineral Trioxide Aggregate  Mineral trioxide aggregate (MTA) is a biocompatible dental material composed of tricalcium silicate, dicalcium silicate, tricalcium aluminate, and bismuth oxide. It promotes dentinogenesis, has excellent sealing ability, and resists moisture. Used in endodontics for pulp capping, apexification, and perforation repair, MTA enhances healing due to its bioactivity and antimicrobial properties. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Healthy children between 4-10 years of age with Frankl’s behaviour
rating scale of 3 and 4.
2. One or more restorable carious primary molars with deep carious
lesions approximating or reaching the pulp after Radiograph examination.
3.Pain does not persist after the removal of stimulus.
4.Presence of at least two-thirds root length.
5.No widening of Periodontal Ligament (PDL) space and no apical or furcal radiolucency. 
 
ExclusionCriteria 
Details  1. Children exhibiting Frankl’s behaviour rating scale of 1 and 2.
2. History of pathological mobility, tenderness on percussion, internal
or external resorption, swelling or sinus tract.
3. Hemostasis not achieved within 5 minutes after coronal pulp
amputation.
4. History of spontaneous or persistent pain.
5. No Pulpal exposure while excavation of caries.
6. Patient or parent not willing to be part of the study. 
 
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 
Clinical and Radiographic Success  Clinical and Radiographic outcome will be assessed at baseline, 3 months, 6 months, 9 months, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   04/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [salonisjoshi13@gmail.com].

  6. For how long will this data be available start date provided 30-09-2027 and end date provided 30-09-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study is a randomised double-blind parallel multi arm trial, comparing and evaluating the use of X based hydroxyapatite, feracrylum gel, and mineral trioxide aggregate as pulpotomy agent in primary molars in 60 children who reported to the outpatient department of Department of paediatric dentistry at Terna dental College. The primary outcome measures the clinical and radiographic success of these three medicaments when used as pulpotomy agents in children between the age group of 4 to 10 years of age. The study operates on the null hypothesis that there is no difference in the clinical and radiographic success rate of these three medicaments. 
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