Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

NCT ID: NCT06945965

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-03-01

Brief Summary

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The aim of this study is to evaluate and compare the regenerative potentials of Injectable Platelet-Rich Fibrin (I-PRF), Platelet-Rich Fibrin (PRF), and Blood Clot (BC) as different scaffolds regarding:

Radiographic outcomes (increase of root length, increase in thickness of dentinal wall, healing of periapical lesion, and apical closure).

Clinical outcomes in the treatment of young, immature permanent teeth with necrotic pulps.

Detailed Description

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Conditions

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Endodontic Disease Regenerative Endodontics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The trial design of this study is planned to be a double-blinded design in which the participant and the statistician will be blinded, and only the operator knows which treatment the patient will receive.

Study Groups

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Regeneration with Injectable platelet-rich fibrin (i-PRF) scaffold

10 ml of venous blood was drawn from the patient's arm. Then it was collected in a sterile tube without anticoagulant.

* The collected blood was centrifuged immediately.
* The separated plasma and platelets form a light-yellow-colored layer, which is situated at the top of the tube. This is then aspirated using a syringe with a needle and amounts to a partially active injectable form.

Group Type EXPERIMENTAL

Injectable platelet-rich fibrin (i-PRF) scaffold

Intervention Type PROCEDURE

The separated plasma and platelets form a light-yellow-colored layer, which is situated at the top of the tube. This is then aspirated using a syringe with a needle (partially active injectable form).

Regeneration with platelet-rich fibrin (PRF)scaffold

10 ml venous blood was drawn from the patient's arm

* Then it was collected in a sterile tube without anticoagulant.
* The collected blood was centrifuged immediately.
* Following the centrifugation, the fibrin clot was formed in the middle of the tube between the red corpuscles at the bottom and acellular plasma at the top.

Group Type EXPERIMENTAL

platelet-rich fibrin (PRF)scaffold

Intervention Type PROCEDURE

The fibrin clot was removed from the test tube with sterile tweezers, then cut into fragments, then placed incrementally in the canal space below the CEJ using hand pluggers (without prior induction of apical bleeding).

Regeneration with blood clot (BC) scaffold

The file will be passed 2 mm beyond the apical end to induce bleeding inside the canal till approximately 2-3 mm below the CEJ.

Group Type ACTIVE_COMPARATOR

blood clot (BC) scaffold

Intervention Type PROCEDURE

A sterile saline-soaked cotton pellet was placed into the canal 2 mm below the orifice for 15 minutes to form a blood clot.

Interventions

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Injectable platelet-rich fibrin (i-PRF) scaffold

The separated plasma and platelets form a light-yellow-colored layer, which is situated at the top of the tube. This is then aspirated using a syringe with a needle (partially active injectable form).

Intervention Type PROCEDURE

platelet-rich fibrin (PRF)scaffold

The fibrin clot was removed from the test tube with sterile tweezers, then cut into fragments, then placed incrementally in the canal space below the CEJ using hand pluggers (without prior induction of apical bleeding).

Intervention Type PROCEDURE

blood clot (BC) scaffold

A sterile saline-soaked cotton pellet was placed into the canal 2 mm below the orifice for 15 minutes to form a blood clot.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Necrotic immature permanent anterior teeth.
* Teeth not indicated for post/core final restoration.
* Radiographically: The root has incomplete development with an apical opening of more than 1 mm.

Exclusion Criteria

* Medically compromised patients with blood and immunity disorders. Family history of autoimmune disorder. Also, patients with physical or mental handicapping conditions.
* Teeth with questionable restorability of the remaining crown/root structure.
* Pathological tooth mobility.
* Radiographically: Evidence of root fracture or root resorption (external or internal).
Minimum Eligible Age

6 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

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Riham Karam Ahmed

Ass.Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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shehab M Mohamed, Phd

Role: STUDY_DIRECTOR

British University In Egypt

Locations

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British University in Egypt

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Masuki H, Okudera T, Watanebe T, Suzuki M, Nishiyama K, Okudera H, Nakata K, Uematsu K, Su CY, Kawase T. Growth factor and pro-inflammatory cytokine contents in platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), advanced platelet-rich fibrin (A-PRF), and concentrated growth factors (CGF). Int J Implant Dent. 2016 Dec;2(1):19. doi: 10.1186/s40729-016-0052-4. Epub 2016 Aug 22.

Reference Type BACKGROUND
PMID: 27747711 (View on PubMed)

El Bagdadi K, Kubesch A, Yu X, Al-Maawi S, Orlowska A, Dias A, Booms P, Dohle E, Sader R, Kirkpatrick CJ, Choukroun J, Ghanaati S. Reduction of relative centrifugal forces increases growth factor release within solid platelet-rich-fibrin (PRF)-based matrices: a proof of concept of LSCC (low speed centrifugation concept). Eur J Trauma Emerg Surg. 2019 Jun;45(3):467-479. doi: 10.1007/s00068-017-0785-7. Epub 2017 Mar 21.

Reference Type BACKGROUND
PMID: 28324162 (View on PubMed)

Metlerska J, Fagogeni I, Nowicka A. Efficacy of Autologous Platelet Concentrates in Regenerative Endodontic Treatment: A Systematic Review of Human Studies. J Endod. 2019 Jan;45(1):20-30.e1. doi: 10.1016/j.joen.2018.09.003. Epub 2018 Nov 13.

Reference Type BACKGROUND
PMID: 30446403 (View on PubMed)

Murray PE. Platelet-Rich Plasma and Platelet-Rich Fibrin Can Induce Apical Closure More Frequently Than Blood-Clot Revascularization for the Regeneration of Immature Permanent Teeth: A Meta-Analysis of Clinical Efficacy. Front Bioeng Biotechnol. 2018 Oct 11;6:139. doi: 10.3389/fbioe.2018.00139. eCollection 2018.

Reference Type BACKGROUND
PMID: 30364277 (View on PubMed)

Other Identifiers

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Regenerative Endodontic

Identifier Type: -

Identifier Source: org_study_id

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