PRF vs. Graftless Sinus Lift With Implant Placement

NCT ID: NCT07090694

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-08-31

Brief 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

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Graftless Sinus Elevation with Simultaneous Implant Placement

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.

Group Type: EXPERIMENTAL

Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement

Intervention Type: PROCEDURE

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

PRF-Grafted Sinus Elevation with Simultaneous 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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

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.

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adults aged 25 to 65 years
• Patients with one or more missing posterior maxillary teeth
• Residual alveolar bone height between 5 mm and 7 mm, confirmed by CBCT
• Good oral hygiene and motivation for implant therapy
• Adequate inter-arch space for prosthetic rehabilitation
• Absence of maxillary sinus pathology on radiographic assessment
• Patients willing to undergo single-stage implant placement with sinus lift
• Signed informed consent

Exclusion Criteria

• Systemic diseases or medical conditions affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis, immunocompromised status)
• History of radiation therapy in the head and neck region
• Use of medications influencing bone turnover (e.g., bisphosphonates, corticosteroids)
• Active periodontal disease or poor oral hygiene
• Smoking or tobacco use
• Parafunctional habits such as bruxism or clenching
• Pregnancy or breastfeeding
• Known bleeding disorders or abnormal coagulation profiles
• Presence of maxillary sinus infection or pathology
• Inability to attend follow-up visits or comply with study protocol

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dar Al Uloom University

OTHER

Sponsor Role: lead

Responsible Party

Sally Abd-ElMeniem ElHaddad

Assist. Prof. Periodontology and Oral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SREIC College of Dentistry, Dar AlUloom University, Scientific Committee

Role: STUDY_DIRECTOR

Dar AlUloom University, SA

Locations

College of Dentistry, Dar AlUloom University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

038- 003- 2025

Identifier Type: -

Identifier Source: org_study_id