NCT06662604

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

October 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2026

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

October 25, 2024

Last Update Submit

October 26, 2024

Conditions

Maxillary Cyst

Keywords

maxillary cystbone marrow stem cellsplatelet rich fibrin PRFbone graftbone reconstructionjaw cyst

Outcome Measures

Primary Outcomes (1)

  • cyst volume

    volumetric analysis of cystic defect 3, 6 months after treatment .

    preoperative and 3, 6 months postoperative.

Study Arms (2)

Group A (Stem cells ,PRF group) intervention group

EXPERIMENTAL
Biological: Bone marrow stem cells concentrate , platelet rich fibrin , bone graft

Group B (PRF group)

ACTIVE COMPARATOR
Biological: platelet rich fibrin and bone graft

Interventions

Bone marrow stem cells concentrate , platelet rich fibrin , bone graftBIOLOGICAL

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

Group A (Stem cells ,PRF group) intervention group
platelet rich fibrin and bone graftBIOLOGICAL

All participants will treated with platelet rich fibrin PRF , bone graft.

Group B (PRF group)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 37918253BACKGROUND

  • 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: 37277026BACKGROUND

  • 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: 30210552BACKGROUND

  • 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: 23129455BACKGROUND

Related Links

MeSH Terms

Conditions

Jaw Cysts

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

Bone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Central Study Contacts

Motea Abdulsalm Sanad, PHD

CONTACT

+20 1090696248matea.sanad@dentistry.cu.edu.eg

Tareq El-Ghareeb, Professor

CONTACT

+201282931864t.elghareeb@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2024

First Posted

October 29, 2024

Study Start

October 26, 2024

Primary Completion

September 17, 2025

Study Completion

February 22, 2026

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share