NCT07348198

Histologic and Histomorphometric Evaluation of Lateral Maxillary Sinus Augmentation With or Without Platelet-Rich Fibrin

Histologic and Histomorphometric Evaluation of Lateral Maxillary Sinus Augmentation Using Demineralized Freeze-Dried Bone Allograft With or Without Platelet-Rich Fibrin: A Prospective Split-Mouth Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates bone healing after lateral maxillary sinus lift surgery performed prior to dental implant placement. This surgical procedure is commonly used when there is insufficient bone height in the upper jaw to support dental implants. Patients who required sinus lift surgery on both sides of the upper jaw were included in the study. In each patient, one side was treated with a demineralized freeze-dried bone allograft (DFDBA) alone, while the opposite side received the same bone graft combined with platelet-rich fibrin (PRF). PRF is a blood-derived material prepared from the patient's own blood and is thought to support tissue healing. The treatment side receiving PRF was determined randomly. Six months after the sinus lift surgery, dental implants were placed. At that time, small bone samples were collected from the grafted areas. These samples were examined under a microscope to assess new bone formation and the amount of remaining graft material. The purpose of this study was to determine whether adding PRF to DFDBA improves bone regeneration compared with DFDBA alone during lateral maxillary sinus augmentation.v

Detailed description

This study was designed as a prospective randomized split-mouth clinical investigation to assess bone regeneration following lateral maxillary sinus augmentation using two different grafting approaches. Patients presenting with bilateral posterior maxillary edentulism and requiring sinus floor elevation prior to dental implant placement were enrolled. Each patient received demineralized freeze-dried bone allograft (DFDBA) alone on one side and DFDBA combined with platelet-rich fibrin (PRF) on the contralateral side, with treatment allocation determined randomly. All sinus augmentation procedures were performed using a standardized lateral window technique. Platelet-rich fibrin was prepared from autologous venous blood immediately before surgery according to established centrifugation protocols. A fixed healing period of six months was observed prior to implant placement. During implant surgery, bone core specimens were harvested from the grafted sinus regions using trephine burs. Histologic and histomorphometric analyses were conducted in a blinded manner to quantify tissue composition, including newly formed bone, residual graft material, and connective tissue. The study aimed to compare the regenerative outcomes of the two grafting strategies and to evaluate the adjunctive role of PRF when combined with an osteoinductive allograft material in lateral maxillary sinus augmentation.

Conditions

• Maxillary Sinus Augmentation
• Posterior Maxillary Atrophy

Interventions

Type	Name	Description
PROCEDURE	Lateral Maxillary Sinus Augmentation With DFDBA	Lateral sinus floor elevation using demineralized freeze-dried bone allograft for bone augmentation prior to implant placement.
PROCEDURE	Lateral Maxillary Sinus Augmentation With DFDBA and PRF	Lateral sinus floor elevation using demineralized freeze-dried bone allograft combined with autologous platelet-rich fibrin.

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-10-10
• Completion: 2025-10-22
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: Turkey (Türkiye)