Clinical trial NCT06945965: Evaluation of Different Scaffolds in Regenerative Endodontic Treatment
Official title: Evaluation of Different Scaffolds in Regenerative Endodontic Treatment of Immature Non-Vital Permanent Teeth and Their Release of Growth Factors: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Disease
Regenerative Endodontics
Keywords: PRF
Regeneration
Blood Clot
Scaffolds
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Root Length
timeFrame: 12 months
measure: Root dentine thickness
timeFrame: 12 months
measure: Apical foramen diameter
timeFrame: 12months
measure: Bony lesion volume
timeFrame: 12 months
Secondary outcomes:
measure: Pulp sensibility
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: British University in Egypt
Study officials:
affiliation: British University In Egypt
name: shehab M Mohamed, Phd
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.