A Phase 1 interventional study of Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement and Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement in Maxillary Sinus Floor Augmentation, Alveolar Bone Loss and Atrophy, sponsored by Dar Al Uloom University. Enrolling by invitation at 1 site in Saudi Arabia. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Dar Al Uloom University · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to evaluate the effectiveness of sinus floor elevation using platelet-rich fibrin (PRF) compared to a graftless approach in adult patients with atrophic posterior maxilla (residual bone height 5-7 mm) requiring dental implant rehabilitation. The main questions it aims to answer are:
Does PRF enhance bone height gain more effectively than graftless sinus elevation? Does PRF improve implant stability and reduce marginal bone loss compared to the graftless approach? Researchers will compare the outcomes of PRF-grafted implants versus non-grafted implants to see if PRF improves radiographic and clinical results in single-stage implant placement.
Participants will:
Undergo internal sinus lift via crestal drilling approach
Be randomly assigned to one of two groups:
Group I: sinus lift without graft material Group II: sinus lift with PRF as the sole grafting material Receive simultaneous dental implant placement during the sinus lift Be monitored through clinical exams and radiographic imaging over 6 months postoperatively
This randomized controlled clinical trial investigates the clinical and radiographic outcomes of crestal sinus floor elevation in the atrophic posterior maxilla, comparing two approaches: one using platelet-rich fibrin (PRF) as a sole grafting material and another performed without any grafting material. Both interventions are combined with single-stage dental implant placement. The rationale for this study is based on emerging evidence suggesting that graftless techniques, relying on blood clot stabilization and tenting of the sinus membrane, may be sufficient to induce predictable bone formation, especially when residual alveolar bone height is ≥5 mm.
The study involves adult patients presenting with edentulous posterior maxillary regions and limited vertical bone height due to sinus pneumatization and ridge resorption.
Participants are randomly allocated to either PRF or graftless groups. Both groups undergo transcrestal sinus elevation through sequential osteotomy, followed by immediate implant placement under a standardized surgical and prosthetic protocol.
Primary outcomes include radiographic bone gain and implant stability quotient (ISQ), while secondary outcomes include marginal bone loss and peri-implant clinical parameters. Radiographic evaluation is conducted using CBCT imaging at baseline and 6 months postoperatively. This study aims to provide evidence on whether PRF offers added clinical benefit over natural healing and clot formation in sinus lift procedures performed via the less invasive crestal approach.
318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.
This study's planned enrollment of 8 is below the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Dar Al Uloom University is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Immunosuppression
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Participants in this arm undergo crestal sinus floor elevation without the use of any grafting material. The procedure involves a transcrestal (internal) sinus lift through sequential osteotomy followed by immediate placement of dental implants. The elevated sinus membrane is maintained by the implant fixture alone, allowing for natural blood clot formation and spontaneous bone regeneration.
Procedure: Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement
Participants in this arm undergo crestal sinus floor elevation using platelet-rich fibrin (PRF) as the sole grafting material. PRF is prepared from the patient's own blood via centrifugation and inserted into the osteotomy site. A dental implant is then placed immediately, supporting the sinus membrane and serving as a tent for guided bone regeneration. This technique utilizes PRF's growth factors to promote healing and enhance new bone formation beneath the elevated sinus membrane.
Biological: Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement
This intervention involves a minimally invasive internal (crestal) sinus lift performed without the use of any grafting material. The sinus membrane is elevated using sequential osteotomy drills, and a dental implant is immediately placed into the prepared site. The implant fixture acts as a tent pole, maintaining the lifted membrane and allowing for spontaneous bone regeneration through blood clot formation alone. This graftless method eliminates the need for additional biomaterials and is intended for patients with residual alveolar bone height of 5-7 mm
This intervention utilizes autologous platelet-rich fibrin (PRF) as the sole grafting material during transcrestal sinus floor elevation. PRF is prepared from the patient's own venous blood using centrifugation and inserted into the osteotomy site after sinus membrane elevation. A dental implant is placed simultaneously to support the sinus membrane and stabilize the graft. The biologically active PRF matrix provides a scaffold rich in growth factors (e.g., TGF-β, PDGF, VEGF), promoting accelerated healing and enhanced bone formation beneath the elevated sinus floor. This technique is performed in a single-stage procedure, eliminating the need for synthetic or allogeneic grafts.
Radiographic Bone Height Gain
Vertical bone gain measured using Cone Beam Computed Tomography (CBCT) from the alveolar crest to the elevated sinus floor. The measurement is taken at baseline (preoperatively) and compared with measurements at 6 months postoperatively to evaluate the success of sinus augmentation.
Time frame: Baseline and 6 months postoperatively
Implant Stability Quotient (ISQ)
Measurement of primary and secondary implant stability using an Osstell device. ISQ values are recorded at the time of implant placement and at 6 months postoperatively to assess osseointegration and mechanical stability.
Time frame: Immediate postoperative (Day 0) and 6 months postoperatively
Marginal Bone Loss
Radiographic evaluation of crestal bone loss measured at the mesial and distal aspects of the implant using CBCT or standardized periapical radiographs. The difference in marginal bone height from baseline to 6 months will be calculated to assess peri-implant bone preservation.
Time frame: Baseline and 6 months postoperatively
Plan to share: Yes — Demographic data (age, sex) Baseline clinical measurements (residual bone height, CBCT parameters) Implant stability quotient (ISQ) values Radiographic bone gain and marginal bone loss measurements Adverse events or complications (if any)
Supporting information: Study protocol
Time frame: IPD will be available within 6 months after publication of the primary study results, and for 6 month Data will be shared upon reasonable request through direct communication with the principal investigator. Access may be granted via secure data transfer or institutional repository, subject to data use agreement.
Access criteria: Qualified researchers affiliated with academic institutions or regulatory bodies for non-commercial purposes.
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