Maxillary CystPhase 3NCT06662604
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
A Phase 3 study testing Bone marrow stem cells concentrate , platelet rich fibrin , bone graft and platelet rich fibrin and bone graft in people with Maxillary Cyst, run by Cairo University.
Trial 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 ? Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Maxillary Cyst
- What is being tested?
- Bone marrow stem cells concentrate , platelet rich fibrin , bone graft and platelet rich fibrin and bone graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2024to 22 Feb 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with large jaw cyst that endanger vital structures
- Patients with significant medical condition
- age under 18 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
Will the use of bone marrow stem cells with platelet rich fibrin enhance and accelerate the bone regeneration in the upper jaw cystic defects ?
Read the 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 ).
- Conditions
- Maxillary Cyst
- Being tested
- Bone marrow stem cells concentrate , platelet rich fibrin , bone graft, platelet rich fibrin and bone graft
- Keywords
- maxillary cyst, bone marrow stem cells, platelet rich fibrin PRF, bone graft, bone reconstruction, jaw cyst
- Medical subject headings
- Jaw Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
platelet rich fibrin and bone graftBiological
All participants will treated with platelet rich fibrin PRF , bone graft.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Stem cells ,PRF group) intervention group | Experimental | Not described Receives: Biological: Bone marrow stem cells concentrate , platelet rich fibrin , bone graft |
| Group B (PRF group) | Active comparator | Not described Receives: Biological: platelet rich fibrin and bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
cyst volume
volumetric analysis of cystic defect 3, 6 months after treatment .
Measured: preoperative and 3, 6 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start26 Oct 2024 (estimated)
- Primary completion17 Sep 2025 (estimated)
- Study completion22 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maxillary CystStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Motea Abdulsalam Sanad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662604
- Sponsor's protocol ID
- OMFS 3-3-18
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37918253Matsumura-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.
PubMed 37277026Fitzsimmons 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.
PubMed 30210552Manfrini 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.
PubMed 23129455
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06662604
- Acronym / sponsor ID
- OMFS 3-3-18
- Conditions
- Maxillary Cyst
- Keywords
- maxillary cyst, bone marrow stem cells, platelet rich fibrin PRF, bone graft, bone reconstruction, jaw cyst
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Oct 2024 (estimated)
- Primary completion
- 17 Sep 2025 (estimated)
- Study completion
- 22 Feb 2026 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with large jaw cyst that endanger vital structures
- Patients with significant medical condition
- age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow stem cells concentrate , platelet rich fibrin , bone graftAll participants will be treated with Bone marrow stem cells concentrate , platelet rich fibrin , bone graft. | Biological | Group A (Stem cells ,PRF group) intervention group |
| platelet rich fibrin and bone graftAll participants will treated with platelet rich fibrin PRF , bone graft. | Biological | Group B (PRF group) |
Primary outcome
cyst volume
Time frame: preoperative and 3, 6 months postoperative.
volumetric analysis of cystic defect 3, 6 months after treatment .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 37918253Liu 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.
- Background: PubMed 37277026Matsumura-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.
- Background: PubMed 30210552Fitzsimmons 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.
- Background: PubMed 23129455Manfrini 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bone marrow stem cells concentrate , platelet rich fibrin , bone graft and platelet rich fibrin and bone graft in people with Maxillary Cyst, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Motea Abdulsalm Sanad, PHD (+20 1090696248, matea.sanad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cyst volume (time frame: preoperative and 3, 6 months postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662604, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.