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

NCT07348198 | Completed

• 1 other identifier: Biruni Uni. 2015-KAEK-76-23-07
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Maxillary Sinus Augmentation; Posterior Maxillary Atrophy

Keywords

sinus augmentation; Split-mouth design; Platelet-rich fibrin; Histomorphometric analysis; Dental implants; demineralized freeze-dried bone allograft

Outcome Measures

Primary Outcomes (1)

• Histomorphometric New Bone Formation (%)

  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 Outcomes (2)

• Residual Graft Material (%)

  6 months after lateral maxillary sinus augmentation

• Connective Tissue (%)

  6 months after lateral maxillary sinus augmentation

Study Arms (2)

Non- PRF(DFDBA Alone)

EXPERIMENTAL

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

Procedure: Lateral Maxillary Sinus Augmentation With DFDBA

PRF(DFDBA + PRF)

EXPERIMENTAL

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

Interventions

Lateral Maxillary Sinus Augmentation With DFDBA PROCEDURE

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

Non- PRF(DFDBA Alone)

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.

PRF(DFDBA + PRF)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Histological and histomorphometric analyses were performed by a blinded examiner who was unaware of the intervention allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This is a prospective, randomized, split-mouth (within-subject) clinical trial in which each participant receives both interventions on contralateral maxillary sinuses.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: April 7, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 22, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)