Adding erythropoietin to albumin platelet-rich fibrin for transcrestal sinus lift with dental implant placement
Comparison Between Erythropoietin-enhanced Albumin Platelet-rich Fibrin and Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement
This will see if adding erythropoietin to albumin platelet-rich fibrin during transcrestal sinus lifts helps people with reduced upper jaw bone who are getting dental implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07150858 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial enrolls patients with atrophic maxilla and residual bone height of at least 5 mm who require a transcrestal sinus lift and simultaneous implant placement. Participants are randomized to receive either erythropoietin mixed into an albumin platelet-rich fibrin (PRF) gel or albumin PRF gel alone during the transcrestal sinus lift performed with a piezoelectric device, followed by implant placement. Outcomes will be followed with clinical exams and cone-beam CT (CBCT) imaging to measure new bone height and implant stability over the follow-up period. The study compares bone regeneration and implant outcomes between the two treatment arms.
Who should consider this trial
Good fit: Adults of either gender with good oral hygiene, residual crestal bone height ≥5 mm, and no prior maxillary sinus surgery or radiation are ideal candidates.
Not a fit: Patients with recent maxillary radiation, uncontrolled systemic disease (for example uncontrolled diabetes), heavy smoking (≥25 cigarettes/day), anticoagulant therapy, severe sinus disease, large sinus cysts or tumors, or oroantral fistula are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding erythropoietin could improve bone formation and implant stability for patients with limited upper jaw bone.
How similar studies have performed: Some animal and small clinical studies suggest erythropoietin can enhance bone healing, but combining erythropoietin with albumin PRF for transcrestal sinus lifts is relatively novel and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Tumor or large cyst in the maxillary sinus. * Oroantral fistula. * Presence of acute or chronic sinus pathoses or sinus membrane perforation.(
Where this trial is running
Alexandria
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: Hassan M Ruzyqat, BDS
- Email: hassanmohammadrziqat@gmail.com
- Phone: 01555767730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.