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CTRI Number  CTRI/2024/10/075535 [Registered on: 18/10/2024] Trial Registered Prospectively
Last Modified On: 17/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Developing an injectable system from biologically available materials for diseased upper front tooth of child population 
Scientific Title of Study   Development of injectable platelet rich fibrin scaffold reinforced with egg shell-derived biomimetic nanohydoxyapatite seeded with stem cells from human exfoliated deciduous teeth for pulp-dentin bioengineering. 
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. J. Shanti Swarup 
Designation  Senior Assistant Professor 
Affiliation  Tamil Nadu Government Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Tamil Nadu Government Dental College and Hospital, Chennai

Chennai
TAMIL NADU
600003
India 
Phone  04425340441  
Fax    
Email  jsswarup@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. J. Shanti Swarup 
Designation  Senior Assistant Professor 
Affiliation  Tamil Nadu Government Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Tamil Nadu Government Dental College and Hospital, Chennai.

Chennai
TAMIL NADU
600003
India 
Phone  04425340441  
Fax    
Email  jsswarup@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. J. Shanti Swarup 
Designation  Senior Assistant Professor 
Affiliation  Tamil Nadu Government Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Tamil Nadu Government Dental College and Hospital, Chennai.

Chennai
TAMIL NADU
600003
India 
Phone  04425340441  
Fax    
Email  jsswarup@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research P.O.Box 4911 Ansari Nagar New Delhi-110029 India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 J Shanti Swarup  TamilNadu Government Dental College and Hospital  Room number 203, Department of Pediatric and Preventive Dentistry, Tamil Nadu Government Dental College and Hospital, Chennai.
Chennai
TAMIL NADU 
9995648809

jsswarup@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  blood clot scaffold with MTA  teeth in the control group will receive the conventional regeneration therapy in which a scaffold of blood clot capped with Mineral Trioxide aggregate will be used 
Intervention  experimental scaffold   teeth in the experimental group will receive the scaffold of Fibrin glue loaded with E- nanoHA seeded with SHED  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1. Fractured maxillary anterior tooth presenting with symptoms of irreversible pulpitis
2. Tooth with radiographic presence of open apex (Nolla’s stages 7 and 8)
3. Radiographic evidence of apical periodontits (Ostravik’s score 3 and above)
4. Tooth testing negative for pulp vitality (Pulpal blood flow) testing using laser speckled contrast imaging system.
 
 
ExclusionCriteria 
Details  1. Patients not willing to take part in the study
2. Tooth with extensive fracture of crown in which rubber dam clamp cannot be placed
3. Tooth with crown-root fracture/ root fracture
4. Clinical or radiographic presence of alveolar/ maxillofacial bone fractures
5. Tooth presenting with grade II or grade III mobility
6. Patients with known allergy to medicaments used in the study
7. Medically compromised patients with co-existing systemic/ immunocompromised conditions
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Positive response to pulp vitality, radiographic increase in root length, increased radicular dentin thickness and reduction in apical diameter would be considered as primary outcome  a baseline evaluation of teh variables will be recorded and effects of the intervention will be assessed 1, 3, 6, 12, 18 and 24 months after completion of the treatment 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   03/02/2025 
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)   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  

Rationale: Regenerative endodontics deals with restoration of lost pulp-dentin complex using tissue engineering concepts. Appropriate selection of components of tissue engineering triad is essential. Literature shows that Stem cells from exfoliated deciduous teeth (SHED) and Nanohydroxyapatite derived from biowaste such as egg shells(E-nanoHA) has appreciable odontogenic properties. Injectable platelet rich fibrin(i-PRF) exhibits high release of growth factors, cellular migration and can three dimensionally take the shape of the canal. This study proposes to develop a single system of i-PRF scaffold with E-Nano HA and SHED for regeneration of pulp dentin complex

Novelty: Development of a single-phase injectable system of tissue engineering triad utilizing biological wastes such as exfoliated deciduous teeth, egg shells for pulp-dentin regeneration.  

Objectives: Primary:1. Preparation and characterization of E-nanoHA 2. Preparation of  culture of stem cells derived from exfoliated deciduous teeth and to develop experimental injectable platelet rich fibrin scaffold loaded with E nano HA and seeded with SHED 3. Assesing In-vitro bioactivity and cytotoxicity of the developed scaffold using pre-clinical animal model and clinical efficacy using a double-blind randomised control trial. Secondary: To develop a technology transfer package for the newly developed scaffold

Methods: Microwave processed E-nanoHA prepared from egg shell, characterized using SEM, EDAX, XRD and cultured SHED cells would be seeded into the injectable fibrin scaffold. In-vitro bioactivity studies and MTT assay would be done to assess the cytotoxicity. Preclinical animal studies would be done followed by a double-blind randomised control trial comparing the developed scaffold with that of the conventional pulp regeneration method. Data collection and statistical analysis of the data would be done.

Expected Outcomes. Regeneration of pulp–dentin complex established through clinical and radiographic absence of pathology, positive pulpal response, increase in root length, radicular dentin thickness and reduction in apical diameter 
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