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CompletedNCT06945965Updated Apr 27, 2025

Evaluation of Different Scaffolds in Regenerative Endodontic Treatment

An interventional study of Injectable platelet-rich fibrin (i-PRF) scaffold and platelet-rich fibrin (PRF)scaffold in Endodontic Disease and Regenerative Endodontics, sponsored by British University In Egypt. Completed at 1 site in Egypt. Open to participants aged 6 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by British University In Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Sep 2021, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Endodontic Disease
  • Regenerative Endodontics

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Keywords

  • PRF
  • Regeneration
  • Blood Clot
  • Scaffolds
03

In context

Dental Pulp Diseases

125 studies on the registry are indexed under Dental Pulp Diseases; 38 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 103 interventional studies indexed under Dental Pulp Diseases.

Browse Dental Pulp Diseases studies →

Lead sponsor

British University In Egypt is the lead sponsor of 67 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    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.

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

  • Experimental
    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.

    Procedure: platelet-rich fibrin (PRF)scaffold

  • Active comparator
    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.

    Procedure: blood clot (BC) scaffold

Interventions

  • ProcedureInjectable 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).

  • Procedureplatelet-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).

  • Procedureblood 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. 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.

    Time frame: 12months

  4. 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.

    Time frame: 12 months

Secondary outcomes

  1. Pulp sensibility

    response to the cold with ethyl chloride and/or electrical pulp testing.

    Time frame: 12 months

07

Study locations

1 site
  • British University in Egypt
    Cairo, 1306, Egypt
08

References and documents

Publications

  • 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. PubMed 27747711 ↗
  • 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. PubMed 28324162 ↗
  • 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. PubMed 30446403 ↗
  • 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. PubMed 30364277 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06945965
Lead sponsor
British University In Egypt
Responsible party
Riham Karam Ahmed (Ass.Lecturer, British University In Egypt) — Principal investigator
First posted
Apr 27, 2025
Start date
Sep 1, 2021
Primary completion
Mar 1, 2025
Completion
Mar 1, 2025
Last update
Apr 27, 2025

Study contacts

shehab M Mohamed, Phd
study director · British University In Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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