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Developing an injectable system from biologically available materials for diseased upper front tooth of child population

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. - nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075535
Enrollment
30
Registered
2024-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K041- Necrosis of pulp

Interventions

Intervention1: experimental scaffold: teeth in the experimental group will receive the scaffold of Fibrin glue loaded with E- nanoHA seeded with SHED Control Intervention1: blood clot scaffold with MT

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Positive response to pulp vitality, radiographic increase in root length, increased radicular dentin thickness and reduction in apical diameter would be considered as primary outcomeTimepoint: 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

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr. J. Shanti Swarup

Tamil Nadu Government Dental College and Hospital

jsswarup@gmail.com04425340441

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026