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NCT Number: NCT07348198

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lateral Maxillary Sinus Augmentation With DFDBA

Procedure

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

Lateral Maxillary Sinus Augmentation With DFDBA and PRF

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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