Maxillary SinusPhase 3NCT05134753
PRF Versus Advanced PRF in Sinus Augmentation
A Phase 3 study testing Advanced PRF in people with Maxillary Sinus, run by Cairo University.
Trial summary
In the present study the main hypothesis , Advanced PRF will improve the bone quality and quantity in sinus augmentation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillary Sinus
- What is being tested?
- Advanced PRF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2022to 1 Sep 2022
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The Patients with missing posterior maxillary teeth with insufficient available bone for implant placement indicating the need for maxillary sinus floor augmentation before implantation.
- 2. The Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- 3. The Patients should be free from any sinus disease that might affect the health and integrity of the sinus lining.
- 4. Assign an informed consent to be involved in the study.
Who cannot join
- Patients with any systemic disease that may affect normal healing. 2. Patients with any sinus disease.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Platelet Rich Fibrin Versus Advanced Platelet Rich Fibrin as Bone Graft Material in Sinus Augmentation (Randomized Controlled Clinical Trial)
In the present study the main hypothesis , Advanced PRF will improve the bone quality and quantity in sinus augmentation
- Conditions
- Maxillary Sinus
- Being tested
- Advanced PRF, Control
- Keywords
- PRF, Advanced PRF, Sinus augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced PRFBiological
Advanced PRF will be placed for patients undergoing sinus augmentation
ControlBiological
PRF will be placed for patients undergoing sinus augmentation
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Patients will undergo sinus augmentation with advanced PRF Receives: Biological: Advanced PRF |
| Controlled arm | Placebo comparator | Patients will undergo sinus augmentation with PRF Receives: Biological: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone quality
Histological analysis for core biopsies Available bone quality will be evaluated by measuring the Total Bone Volume (TBV)
Measured: Six months
Secondary outcomes (1)
Bone quantity
- Linear height measurements changes of the bone will be evaluated via panoramic X-rays
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start30 Jan 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahinour magdy mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134753
- Sponsor's protocol ID
- PRF and sinus augmentation
- Status last verified
- Dec 2021
- First submitted
- 15 Nov 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Fibrin Versus Advanced Platelet Rich Fibrin as Bone Graft Material in Sinus Augmentation (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05134753
- Acronym / sponsor ID
- PRF and sinus augmentation
- Conditions
- Maxillary Sinus
- Keywords
- PRF, Advanced PRF, Sinus augmentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 26 Nov 2021 (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.
In the present study the main hypothesis , Advanced PRF will improve the bone quality and quantity in sinus augmentation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Biological: Advanced PRFPatients will undergo sinus augmentation with advanced PRF |
| Controlled arm | Placebo comparator | Biological: ControlPatients will undergo sinus augmentation with PRF |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The Patients with missing posterior maxillary teeth with insufficient available bone for implant placement indicating the need for maxillary sinus floor augmentation before implantation.
- 2. The Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- 3. The Patients should be free from any sinus disease that might affect the health and integrity of the sinus lining.
- 4. Assign an informed consent to be involved in the study.
Key exclusion criteria (2 listed)
- Patients with any systemic disease that may affect normal healing. 2. Patients with any sinus disease.
- -
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 |
|---|---|---|
| Advanced PRFAdvanced PRF will be placed for patients undergoing sinus augmentation | Biological | Study arm |
| ControlPRF will be placed for patients undergoing sinus augmentation | Biological | Controlled arm |
Primary outcome
Bone quality
Time frame: Six months
Histological analysis for core biopsies Available bone quality will be evaluated by measuring the Total Bone Volume (TBV)
1 secondary outcome
Bone quantity
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Advanced PRF in people with Maxillary Sinus, 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 4 inclusion and 2 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 23 Dec 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahinour Magdy Mohamed (01223944859 ext. 02, Mahinour_mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone quality (time frame: Six months). 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 23 Dec 2021.