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Not yet recruiting NCT06662604

Using of Bone Marrow Stem Cell Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Reconstruction of Upper Jaw Bony Cystic Defects, Comparing with Platelet Rich Fibrin with Bone Graft

Phase III Interventional Maxillary Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bone marrow stem cells concentrate , platelet rich fibrin , bone graft, platelet rich fibrin and bone graft.
Who it may be relevant to
Registry conditions: Maxillary Cyst. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Bone Marrow Stem Cells Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Regeneration of Maxillary Cystic Defects Versus Platelet Rich Fibrin with Bone Graft (a Randomized Controlled Trial)

Overview

Will the use of bone marrow stem cells with platelet rich fibrin enhance and accelerate the bone regeneration in the upper jaw cystic defects ?

Detailed description

Reconstruction of critical size bone defect in maxillofacial surgery is a great challenge, current practice of bone reconstruction still having problems like delay in bone regeneration (up to 12 months) and bone graft failure and low availability of autogenous bone graft.

last decade stem cells therapy gained great interest, in many studies Bone marrow stem cells showed promising result in bone regeneration enhancing .

Platelet Rich Fibrin PRF also capability of enhancing bone and tissue regeneration by releasing of certain protein molecules call growth factors that initiate sequential biological events resulting in stem cells migration into the site of bone defect and differentiation to bone formation cells (osteoblast cells ).

Interventions

  • Biological Bone marrow stem cells concentrate , platelet rich fibrin , bone graft
    All participants will be treated with Bone marrow stem cells concentrate , platelet rich fibrin , bone graft.
  • Biological platelet rich fibrin and bone graft
    All participants will treated with platelet rich fibrin PRF , bone graft.

Primary outcome measures

  • cyst volume [Time frame: preoperative and 3, 6 months postoperative.]

Eligibility criteria

Inclusion criteria

  • Age range 18-50 years
  • Patients with a critical size maxillary cyst. (>3 cm)
  • Patients that free of any significant medical conditions that could affect healing or outcomes.

Exclusion criteria

  • Patients with large jaw cyst that endanger vital structures
  • Patients with significant medical condition
  • age under 18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Liu M, Liu Y, Luo F. The role and mechanism of platelet-rich fibrin in alveolar bone regeneration. Biomed Pharmacother. 2023 Dec;168:115795. doi: 10.1016/j.biopha.2023.115795. Epub 2023 Nov 2. PMID 37918253
  • Matsumura-Matsuo M, To M, Okudera T, Matsuo M. Regeneration processes of alveolar bone and microvascular changes after the application of platelet-rich fibrin. J Oral Biosci. 2023 Sep;65(3):218-225. doi: 10.1016/j.job.2023.05.004. Epub 2023 Jun 3. PMID 37277026
  • Fitzsimmons REB, Mazurek MS, Soos A, Simmons CA. Mesenchymal Stromal/Stem Cells in Regenerative Medicine and Tissue Engineering. Stem Cells Int. 2018 Aug 19;2018:8031718. doi: 10.1155/2018/8031718. eCollection 2018. PMID 30210552
  • Manfrini M, Di Bona C, Canella A, Lucarelli E, Pellati A, D'Agostino A, Barbanti-Brodano G, Tognon M. Mesenchymal stem cells from patients to assay bone graft substitutes. J Cell Physiol. 2013 Jun;228(6):1229-37. doi: 10.1002/jcp.24276. PMID 23129455

Identifiers

NCT: NCT06662604 · OMFS 3-3-18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗