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

NCT ID: NCT07348198

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2025-10-22

Brief 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

Study Design

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

Study Groups

Non- PRF(DFDBA Alone)

Lateral maxillary sinus augmentation performed using demineralized freeze-dried bone allograft (DFDBA) alone.

Group Type: EXPERIMENTAL

Lateral Maxillary Sinus Augmentation With DFDBA

Intervention Type: PROCEDURE

Lateral sinus floor elevation using demineralized freeze-dried bone allograft for bone augmentation prior to implant placement.

PRF(DFDBA + PRF)

Lateral sinus floor elevation using demineralized freeze-dried bone allograft combined with autologous platelet-rich fibrin.

Group Type: EXPERIMENTAL

Lateral Maxillary Sinus Augmentation With DFDBA and PRF

Intervention Type: PROCEDURE

Lateral sinus floor elevation using demineralized freeze-dried bone allograft combined with autologous platelet-rich fibrin.

Interventions

Lateral Maxillary Sinus Augmentation With DFDBA

Lateral sinus floor elevation using demineralized freeze-dried bone allograft for bone augmentation prior to implant placement.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 to 70 years.
• Patients requiring bilateral lateral maxillary sinus augmentation for dental implant placement.
• Adequate residual alveolar bone height allowing for lateral sinus floor elevation.
• Good general health (ASA I or II).
• Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria

• Presence of systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis).
• History of head and neck radiotherapy.
• Use of medications known to affect bone healing (e.g., bisphosphonates, corticosteroids).
• Active sinus pathology or chronic sinusitis.
• Heavy smoking (>10 cigarettes per day).
• Pregnancy or lactation.
• Poor oral hygiene or untreated periodontal disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Erkin Doğan

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marmara University

Istanbul, Maltepe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Biruni Uni. 2015-KAEK-76-23-07

Identifier Type: -

Identifier Source: org_study_id