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

NCT07121348 | Active Not Recruiting DMC

• 1 other identifier: REGEN2025-NH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Necrotic Immature Permanent Incisors

Outcome Measures

Primary Outcomes (1)

• apical closure assessed radiographically

  radiographic evaluation of apical closure as reduction or elimination of the apical opening of the root

  12 months after treatment

Study Arms (4)

Platelet Rich Fibrin (PRF only)

EXPERIMENTAL

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.

Procedure: Platelet rich fibrin

Mesoporous Silica Nanoparticles scaffold (MSN)

EXPERIMENTAL

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.

Procedure: Platelet rich fibrin

Hyaluronic Acid Nanoparticles scaffold (HA)

EXPERIMENTAL

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.

Procedure: Platelet rich fibrin

Pomegranate ( punica granatum) Extract Nanoparticles scaffold

EXPERIMENTAL

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.

Procedure: Platelet rich fibrin

Interventions

Platelet rich fibrin PROCEDURE

platelet rich fibrin is obtained by removing the middle layer from a centrifuged blood sample and is rich with platelets that plays an important role in tissue regeneration mesoporous silica nanoparticles are high surface area and excellent biocompatibility and enhance the outcome hyalurnic acid nanoparticles are high water capacity and involved in cell proliferation and adhesion and help in tissue regeneration pomegranate nanoparticles has anti-inflammatory and antibacterial effect and also help in tissue proliferation and regeneration

Also known as: mesoporous silica nanoparticles, hyaluronic acid nanoparticles, pomegranate (punica granatum) nanoparticles

Hyaluronic Acid Nanoparticles scaffold (HA); Mesoporous Silica Nanoparticles scaffold (MSN); Platelet Rich Fibrin (PRF only); Pomegranate ( punica granatum) Extract Nanoparticles scaffold

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry,Tanta University

Tanta, Gharbia Governorate, Egypt

Location

Related Links

• evaluate the antimicrobial effectiveness of two irrigation medication protocols

MeSH Terms

Interventions

Nanoparticles

Intervention Hierarchy (Ancestors)

Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of Different NanoScaffolds on Pulp Regeneration in Non-Vital Immature Permanent Teeth (Randomized Clinical Trial)

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 13, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication of the primary results and available for 2 years
• Access Criteria: shared with qualified researchers upon reasonable request. requests should include a proposal outlining the intended use of the data

Locations

EG (1)