| 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
|
|
|
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
|
|
|
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 |