Sinus LiftingNCT07150858
Erythropoietin - Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement
A study testing Erythropoietin and albumin PRF gel + implant placement and Albumin PRF gel +implant placement in people with Sinus Lifting, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence trans crestal sinus lifting with albumin platelet rich plasma. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Sinus Lifting
- What is being tested?
- Erythropoietin and albumin PRF gel + implant placement and Albumin PRF gel +implant placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2025to 25 Jul 2026
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Residual bone height not less than 5 mm measured from crestal bone to sinus floor.
- Both genders.
- Good oral hygiene
- No previous surgery or radiation treatment on the maxillary sinus
Who cannot join
- Recent radiation therapy in maxilla.
- Uncontrolled systemic diseases such as diabetes mellitus.
- Heavy smoker (those who smoke ≥ 25 cigarettes a day).
- Alcohol abuse.
- Patient on anticoagulant drug
- Severe allergic rhinitis.
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- Tumor or large cyst in the maxillary sinus.
- Oroantral fistula.
- Presence of acute or chronic sinus pathoses or sinus membrane perforation.(
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
Hassan M Ruzyqat, BDS, 01555767730, hassanmohammadrziqat@gmail.com
Hassan M Ruzyqat, BDS
About this study
Official title: Comparison Between Erythropoietin-enhanced Albumin Platelet-rich Fibrin and Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement
Background: Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence trans crestal sinus lifting with albumin platelet rich plasma.
Aim of the study: To compare between erythropoietin and albumin platelet rich fibrin transcrestal sinus lifting versus albumin platelet rich fibrin transcrestal sinus lifting using piezoelectric device in patients with atrophic maxilla.
Methods: This study will be carried out as a randomized
- Conditions
- Sinus Lifting
- Being tested
- Erythropoietin and albumin PRF gel + implant placement, Albumin PRF gel +implant placement
- Keywords
- Transcrestal sinus lifting, erythropoitein, albumin PRF, Peizo electric device, Dental implants, CBCT.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin and albumin PRF gel + implant placementOther
This group will be treated by transcrestal sinus lifting with erythropoietin and albumin PRF gel with simultaneous implant placement.
Albumin PRF gel +implant placementOther
This group (the Control group) will be treated with transcrestal sinus lifting using albumin PRF gel, with simultaneous implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin and albumin PRF gel | Experimental | Not described Receives: Other: Erythropoietin and albumin PRF gel + implant placement |
| albumin PRF gel | Active comparator | Not described Receives: Other: Albumin PRF gel +implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
pain will be assessed through a 10 point visual analogue scale (VAS). (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe).
Measured: up to 14 days
Change in edema
Edema will be assessed as follows:
- None (no swelling)
- Mild (intraoral swelling confined to the surgical field)
- Moderate (extra oral swelling in the surgical zone)
- Severe (extraoral swelling spreading beyond the surgical zone)
Measured: up to 14 days
Change in implant stability
implant stability will be assessed using ostell device
Measured: immediate and 4 months
Secondary outcomes (2)
Change in bone gain
amount of sinus bone gain (SBG) which equals implant protrusion length (IPL) added to Peri-implant sinus bone level (PSBL) which is the distance between the apex of the implant and sinus bone level
Measured: baseline and 4 months
Change in bone density
it will be assessed using CBCT
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start25 May 2025
- Primary completion25 Jul 2026 (estimated)
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus LiftingStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150858
- Sponsor's protocol ID
- 1073-5/2025
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 2 Sep 2025
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Erythropoietin-enhanced Albumin Platelet-rich Fibrin and Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT07150858
- Acronym / sponsor ID
- 1073-5/2025
- Conditions
- Sinus Lifting
- Keywords
- Transcrestal sinus lifting, erythropoitein, albumin PRF, Peizo electric device, Dental implants, CBCT.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 25 Jul 2026 (estimated)
- Study completion
- 25 Jul 2026 (estimated)
- First posted
- 2 Sep 2025 (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.
Background: Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence trans crestal sinus lifting with albumin platelet rich plasma.
Aim of the study: To compare between erythropoietin and albumin platelet rich fibrin transcrestal sinus lifting versus albumin platelet rich fibrin transcrestal sinus lifting using piezoelectric device in patients with atrophic maxilla.
Methods: This study will be carried out as a randomized
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin and albumin PRF gel | Experimental | Other: Erythropoietin and albumin PRF gel + implant placement |
| albumin PRF gel | Active comparator | Other: Albumin PRF gel +implant placement |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Residual bone height not less than 5 mm measured from crestal bone to sinus floor.
- Both genders.
- Good oral hygiene
- No previous surgery or radiation treatment on the maxillary sinus
Key exclusion criteria (9 listed)
- Recent radiation therapy in maxilla.
- Uncontrolled systemic diseases such as diabetes mellitus.
- Heavy smoker (those who smoke ≥ 25 cigarettes a day).
- Alcohol abuse.
- Patient on anticoagulant drug
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 |
|---|---|---|
| Erythropoietin and albumin PRF gel + implant placementThis group will be treated by transcrestal sinus lifting with erythropoietin and albumin PRF gel with simultaneous implant placement. | Other | Erythropoietin and albumin PRF gel |
| Albumin PRF gel +implant placementThis group (the Control group) will be treated with transcrestal sinus lifting using albumin PRF gel, with simultaneous implant placement. | Other | albumin PRF gel |
Primary outcome
Change in pain scores
Time frame: up to 14 days
pain will be assessed through a 10 point visual analogue scale (VAS). (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe).
Change in edema
Time frame: up to 14 days
Edema will be assessed as follows: 1. None (no swelling) 2. Mild (intraoral swelling confined to the surgical field) 3. Moderate (extra oral swelling in the surgical zone) 4. Severe (extraoral swelling spreading beyond the surgical zone)
Change in implant stability
Time frame: immediate and 4 months
implant stability will be assessed using ostell device
2 secondary outcomes
Change in bone gain
Time frame: baseline and 4 months
Change in bone density
Time frame: baseline and 4 months
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 2 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythropoietin and albumin PRF gel + implant placement and Albumin PRF gel +implant placement in people with Sinus Lifting, run by Alexandria 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. 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?
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 Hassan M Ruzyqat, BDS (01555767730, hassanmohammadrziqat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: up to 14 days). The study lists 3 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 2 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.