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PRF vs. Graftless Sinus Lift With Implant Placement

NCT07090694 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-07-29

No results posted yet for this study

Summary

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

Conditions

  • Maxillary Sinus Floor Augmentation
  • Alveolar Bone Loss
  • Atrophy
  • Platelet-rich Fibrin
  • Dental Implant

Interventions

PROCEDURE

Graftless 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

BIOLOGICAL

Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement

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.

Sponsors & Collaborators

  • Dar Al Uloom University

    lead OTHER

Principal Investigators

  • SREIC College of Dentistry, Dar AlUloom University, Scientific Committee · Dar AlUloom University, SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07090694 on ClinicalTrials.gov