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

January 9, 2026 updated by: Erkin Doğan, Marmara University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Turkey (Türkiye), 34854
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non- PRF(DFDBA Alone)
Lateral maxillary sinus augmentation performed using demineralized freeze-dried bone allograft (DFDBA) alone.
Procedure: Lateral Maxillary Sinus Augmentation With DFDBA
Lateral sinus floor elevation using demineralized freeze-dried bone allograft for bone augmentation prior to implant placement.
Experimental: PRF(DFDBA + PRF)
Lateral sinus floor elevation using demineralized freeze-dried bone allograft combined with autologous platelet-rich fibrin.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histomorphometric New Bone Formation (%)
Time Frame: 6 months after lateral maxillary sinus augmentation
The percentage of newly formed bone in biopsy samples obtained from the augmented maxillary sinus, evaluated by histomorphometric analysis.
6 months after lateral maxillary sinus augmentation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Graft Material (%)
Time Frame: 6 months after lateral maxillary sinus augmentation
The percentage of residual graft material remaining in biopsy samples obtained from the augmented maxillary sinus, assessed by histomorphometric analysis.
6 months after lateral maxillary sinus augmentation
Connective Tissue (%)
Time Frame: 6 months after lateral maxillary sinus augmentation
The percentage of connective tissue present in biopsy samples obtained from the augmented maxillary sinus, evaluated using histomorphometric analysis.
6 months after lateral maxillary sinus augmentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

October 22, 2025

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biruni Uni. 2015-KAEK-76-23-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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