Bone Loss, AlveolarNCT05985317
Effect of Collagen Versus PRF on BMA Osteogenic Potential
A study testing Collagen membrane over BMAC/bovine graft in sinus lift and PRF membrane over BMAC/bovine graft in sinus lift in people with Bone Loss, Alveolar, run by Cairo University at 1 site in Egypt.
Trial summary
Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and before suturing Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar
- What is being tested?
- Collagen membrane over BMAC/bovine graft in sinus lift and PRF membrane over BMAC/bovine graft in sinus lift
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
- Highly motivated patients
- Age more than 18 years
Who cannot join
- Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
- Patients suffering from any sinus pathosis.
- Patients with conditions that could potentially compromise Bone Marrow ( BM)quality, including history of hematologic malignancy, current chemotherapy, BM suppressive and anti-platelet medications, previous BM Aspiration, or acute illness.
- Heavy smoker (> 20 cigarettes daily)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, 02
Walaa Kadry, Phd
About this study
Official title: Evaluation of Collagen Versus Platelet Rich Fibrin Membrane on the Osteogenic Potential of Bone Marrow Aspirate Concentrate (BMAC) for Lateral Sinus Floor Augmentation : A Randomized Clinical Trial.
Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and before suturing
Read the detailed description
Assessment of the effect of membrane overlying bone marrow aspirate concentrate - bovine graft mixture in sinus lift procedure
- Conditions
- Bone Loss, Alveolar
- Being tested
- Collagen membrane over BMAC/bovine graft in sinus lift, PRF membrane over BMAC/bovine graft in sinus lift
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen membrane over BMAC/bovine graft in sinus liftProcedure or surgery
Collagen membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
PRF membrane over BMAC/bovine graft in sinus liftProcedure or surgery
PRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure
| Study group | Role | What they receive |
|---|---|---|
| Collagen membrane covering BMAC loaded on bovine graft | Active comparator | Collagen membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative Receives: Procedure: Collagen membrane over BMAC/bovine graft in sinus lift |
| PRF membrane covering BMAC loaded on bovine graft | Active comparator | Platelet rich fibrin membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative Receives: Procedure: PRF membrane over BMAC/bovine graft in sinus lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Bone density assessment
Bone density measurements on Cone beam CT/CBCT immediate and 4 months radiographic density measurements in haunsfield units, immediate and 4 months postoperative
Measured: 4 months ( immediate - 4 months postoperative)
Secondary outcomes (1)
Radiographic Bone height assessment
Assessment of bone hight on CBCT, mmediate and at 4 months postoperative
Measured: 4 months ( immediate - 4 months postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start25 Jan 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Kadry, Cairo University
- Investigators
- Eman Said, Study director, Lecturer at Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985317
- Sponsor's protocol ID
- The membrane effect on the BM
- Status last verified
- Aug 2023
- First submitted
- 23 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Collagen Versus Platelet Rich Fibrin Membrane on the Osteogenic Potential of Bone Marrow Aspirate Concentrate (BMAC) for Lateral Sinus Floor Augmentation : A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05985317
- Acronym / sponsor ID
- The membrane effect on the BM
- Conditions
- Bone Loss, Alveolar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 14 Aug 2023 (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.
Utilization of collagen vs PRF membrane over the graft following sinus lift procedure and before suturing
Detailed description
Assessment of the effect of membrane overlying bone marrow aspirate concentrate - bovine graft mixture in sinus lift procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen membrane covering BMAC loaded on bovine graft | Active comparator | Procedure: Collagen membrane over BMAC/bovine graft in sinus liftCollagen membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative |
| PRF membrane covering BMAC loaded on bovine graft | Active comparator | Procedure: PRF membrane over BMAC/bovine graft in sinus liftPlatelet rich fibrin membrane will be used to BMAC loaded on bovine graft . Variables include assessment of the osteogenic potential In terms of bone density measurements of graft immediate and 4 months Postoperative |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
- Highly motivated patients
- Age more than 18 years
Key exclusion criteria (4 listed)
- Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
- Patients suffering from any sinus pathosis.
- Patients with conditions that could potentially compromise Bone Marrow ( BM)quality, including history of hematologic malignancy, current chemotherapy, BM suppressive and anti-platelet medications, previous BM Aspiration, or acute illness.
- Heavy smoker (> 20 cigarettes daily)
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 |
|---|---|---|
| Collagen membrane over BMAC/bovine graft in sinus liftCollagen membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure | Procedure or surgery | Collagen membrane covering BMAC loaded on bovine graft |
| PRF membrane over BMAC/bovine graft in sinus liftPRF membrane to cover BMAC/bovine graft in sinus lift and evaluation of its effect on osteogenic potential of BMAC in sinus lift procedure | Procedure or surgery | PRF membrane covering BMAC loaded on bovine graft |
Primary outcome
Radiographic Bone density assessment
Time frame: 4 months ( immediate - 4 months postoperative)
Bone density measurements on Cone beam CT/CBCT immediate and 4 months radiographic density measurements in haunsfield units, immediate and 4 months postoperative
1 secondary outcome
Radiographic Bone height assessment
Time frame: 4 months ( immediate - 4 months postoperative)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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. This study is not recruiting at the moment.
Eman Said study director
Lecturer at Faculty of Dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen membrane over BMAC/bovine graft in sinus lift and PRF membrane over BMAC/bovine graft in sinus lift in people with Bone Loss, Alveolar, run by Cairo University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walaa Kadry (+201061527359, walaakadry@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Bone density assessment (time frame: 4 months ( immediate - 4 months postoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2023.