Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

NCT06945965 | Completed

• 1 other identifier: Regenerative Endodontic
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endodontic Disease; Regenerative Endodontics

Keywords

PRF; Regeneration; Blood Clot; Scaffolds

Outcome Measures

Primary Outcomes (4)

• Root Length

  the distance between the CEJ and the apical endpoint mesially (M) and distally (D) on the coronal plane and labially (L) and palatally (P) on the sagittal plane. it was measured by a measure length tool in millimeters.

  12 months

• Root dentine thickness

  Root dentine thickness was measured as a line from the outer root canal diameter to the canal lumen in the mesial, distal, buccal, and lingual dentinal walls of the root. It was measured from the axial plane at 4 mm and 8 mm from the CEJ. It was measured by the same length-measuring tool in millimeters.

  12 months

• Apical foramen diameter

  It was measured as a line from the mesial and distal root ends at the coronal plane and from the labial to palatal root ends at the sagittal plane in millimeters.

  12months

• Bony lesion volume

  The volume of each slice of the lesion was calculated by multiplying the area of each cut by the distance of 0.5mm between the tomographic sections. With the sum of the volume of all the slices, the total volume of the bony lesion was obtained in cubic centimeters.

  12 months

Secondary Outcomes (1)

• Pulp sensibility

  12 months

Study Arms (3)

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

EXPERIMENTAL

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.

Procedure: Injectable platelet-rich fibrin (i-PRF) scaffold

Regeneration with platelet-rich fibrin (PRF)scaffold

EXPERIMENTAL

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.

Procedure: platelet-rich fibrin (PRF)scaffold

Regeneration with blood clot (BC) scaffold

ACTIVE COMPARATOR

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.

Procedure: blood clot (BC) scaffold

Interventions

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

platelet-rich fibrin (PRF)scaffold 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 platelet-rich fibrin (PRF)scaffold

blood clot (BC) scaffold 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.

Regeneration with blood clot (BC) scaffold

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

British University in Egypt

Cairo, 1306, Egypt

Location

Related Publications (4)

• 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.

  PMID: 27747711 BACKGROUND

• 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.

  PMID: 28324162 BACKGROUND

• 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.

  PMID: 30446403 BACKGROUND

• 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.

  PMID: 30364277 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Thrombosis

Interventions

proliferation regulatory factors, human urine; Blood Coagulation

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• shehab M Mohamed, Phd

  British University In Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Lecturer

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 27, 2025
• Study Start: September 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)