Oral SinusNCT05797675
Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift
A study testing prf + osseodensification in people with Oral Sinus, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
12 patients with indirect sinus lift will be selected with RBH\>5mm , surgical procedure =osseodensification + Prf+ implant . 1. versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) . 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Sinus
- What is being tested?
- prf + osseodensification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 20 Jul 2022to 30 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medically fit non pregnant no sinus pathology
Who cannot join
- young patients under 18
- sinus pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift : A Randomized Control Trial.
12 patients with indirect sinus lift will be selected with RBH\>5mm , surgical procedure
=osseodensification + Prf+ implant .
- versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) .
- primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn .
- CBCT will be taken before surgery , perioapical x-ray immediately after surgery and CBCT at 6m follow up to be apple to see the differences regarding bone quality and volume.
- Conditions
- Oral Sinus
- Being tested
- prf + osseodensification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prf + osseodensificationProcedure or surgery
Also called platelet concentrates,
prf+ osseodensification in close sinus lift
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Implant therapy and closed sinus lifting with A-PRF Receives: Procedure: prf + osseodensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary stability of implant
by osstel
Measured: 6 months
bone density
measuring and evaluating bone density by cbct
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start20 Jul 2022
- Primary completion20 Nov 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral SinusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hadeel bassam albahar, Arab American University (Palestine)
- Investigators
- hadeel albahar, master, Principal investigator, Arab American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797675
- Sponsor's protocol ID
- AAUP
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 11 Apr 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift : A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05797675
- Acronym / sponsor ID
- AAUP
- Conditions
- Oral Sinus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 4 Apr 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.
12 patients with indirect sinus lift will be selected with RBH\>5mm , surgical procedure
=osseodensification + Prf+ implant .
- versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) .
- primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn .
- CBCT will be taken before surgery , perioapical x-ray immediately after surgery and CBCT at 6m follow up to be apple to see the differences regarding bone quality and volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: prf + osseodensificationImplant therapy and closed sinus lifting with A-PRF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medically fit non pregnant no sinus pathology
Key exclusion criteria (2 listed)
- young patients under 18
- sinus pathology
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 |
|---|---|---|
| prf + osseodensificationAlso: platelet concentrates,prf+ osseodensification in close sinus lift | Procedure or surgery | Test group |
Primary outcome
secondary stability of implant
Time frame: 6 months
by osstel
bone density
Time frame: 6 months
measuring and evaluating bone density by cbct
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
hadeel albahar, master principal investigator
Arab American 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 prf + osseodensification in people with Oral Sinus, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
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 1 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: finished, as of the sponsor's last update on 11 Apr 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 Palestinian Territories. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secondary stability of implant (time frame: 6 months). The study lists 2 primary outcomes in all. 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 11 Apr 2023.