PRF vs. Graftless Sinus Lift With Implant Placement

NCT07090694 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: 038- 003- 2025
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Transcrestal Sinus Lift; Crestal Approach Sinus Floor Elevation; Maxillary Sinus Augmentation; Platelet-Rich Fibrin; Single-Stage Implant Placement; Atrophic Posterior Maxilla

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months postoperatively

Secondary Outcomes (2)

• Implant Stability Quotient (ISQ)

  Immediate postoperative (Day 0) and 6 months postoperatively

• Marginal Bone Loss

  Baseline and 6 months postoperatively

Study Arms (2)

Graftless Sinus Elevation with Simultaneous Implant Placement

EXPERIMENTAL

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

PRF-Grafted Sinus Elevation with Simultaneous Implant Placement

ACTIVE COMPARATOR

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

Interventions

Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement 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

Graftless Sinus Elevation with Simultaneous Implant Placement

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

PRF-Grafted Sinus Elevation with Simultaneous Implant Placement

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dar Al Uloom University: lead

Study Sites (1)

College of Dentistry, Dar AlUloom University

Riyadh, 11512, Saudi Arabia

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Atrophy

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

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

  Dar AlUloom University, SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Periodontology and Oral Medicine

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

SA (1)