Effect of Different NanoScaffolds on Pulp Regeneration in Non-Vital Immature Permanent Teeth (Randomized Clinical Trial)

Tanta University

Status: Active, not recruiting

Conditions: Necrotic Immature Permanent Incisors

Treatments: Procedure: Platelet rich fibrin

Study type: Interventional

Funder types: Other

Identifiers

NCT07121348

REGEN2025-NH

Details and patient eligibility

About

the clinical trial aims to evaluate efficency of different scaffolds in cases of regeneration

Full description

The aim of this study is to evaluate the clinical and radiographic outcome of regenerative endodontic procedures in immature non-vital permanent teeth using different nanoscaffolds (Platelet-rich fibrin, Mesoporous silica nanoparticles, Hyaluronic acid nanoparticles, Pomegranate nanoparticles)

Enrollment: 40 patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:• Patients free from any systemic diseases that may interfer with the normal healing process.

• Maxillary traumatized or cariously exposed non-vital immature anterior teeth.
• Teeth don't need for post and core as a final restoration.
• Radiographic evidence of an apical opening width more than 2 mm with or without periapical radiolucency.
• Teeth without anatomical variations

Exclusion Criteria:• Immunocompromised patients

• Teeth with previous endodontic treatment.
• Teeth with internal or external resorption
• Radiographic evidence of root fracture.
• Lack of patient and parent cooperation.
• Presence of periodontal pocket depth more than 4 mm.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Platelet Rich Fibrin (PRF only)

Experimental group

Description:

patients will recieve canal disinfection followed by induction of bleeding and placement of platelet rich fibrin as the only scaffold before coronal sealing. platelet rich fibrin is obtained br removing the middle layer from a centrifuged blood sample and this is rich in platelets that play role in promoting tissue regeneration.

Treatment:

Procedure: Platelet rich fibrin

Mesoporous Silica Nanoparticles scaffold (MSN)

Experimental group

Description:

patients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing. Mesoporous Silica Nanoparticles are biocompatible with high surface area that used as scaffold for enhancing the outcome.

Treatment:

Procedure: Platelet rich fibrin

Hyaluronic Acid Nanoparticles scaffold (HA)

Experimental group

Description:

patients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing. Hyalornic Acid nanoparticles are biodegradable with high water retention capacity promoting pulp tissue regeneration.

Treatment:

Procedure: Platelet rich fibrin

Pomegranate ( punica granatum) Extract Nanoparticles scaffold

Experimental group

Description:

patients will recieve canal disinfection followed by induction of bleeding and injection of this scaffold directly before coronal sealing. Pomegranate Extract Nanoparticles are synthesized from Punica granatum exract with potential antimicrobial and regenerative properties.

Treatment:

Procedure: Platelet rich fibrin