Comparison of Allograft, Xenograft and Combined Grafting in Maxillary Sinus Augmentation (SINUS-GRAFT)

February 5, 2026 updated by: Sefa Colak, Tokat Gaziosmanpasa University

Radiographic, Histological and Immunohistochemical Evaluation of Allograft, Xenograft, and Combined Grafting in Maxillary Sinus Floor Augmentation: A Prospective Randomized Clinical Study

This prospective randomized clinical study evaluates and compares three different grafting approaches (allograft, xenograft, and combined grafting) used in lateral maxillary sinus augmentation prior to dental implant placement.

Patients with posterior maxillary bone deficiency (residual bone height ≤4 mm) undergoing sinus lift surgery were randomly assigned to one of three grafting groups. Cone-beam computed tomography (CBCT) was used to assess bone height before surgery, immediately after grafting, and at 6 months. During implant placement at 6 months, bone biopsy samples were collected from the grafted sites for histological and immunohistochemical evaluation.

The study aims to assess vertical bone gain, graft height stability, and biological bone healing using osteocalcin, osteopontin, and RUNX2 markers. The results are intended to provide clinically relevant information regarding the volumetric and biological behavior of different graft materials used in maxillary sinus augmentation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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)
    • Tokat Province
      • Tokat Province, Tokat Province, Turkey (Türkiye), 60230
        • Tokat Gaziosmanpaşa University Faculty of Dentistry

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 75 years.
  • Patients presenting with posterior maxillary edentulism requiring dental implant rehabilitation.
  • Residual alveolar bone height of 4 mm or less, indicating the need for lateral maxillary sinus augmentation.
  • Patients suitable for lateral sinus lift surgery based on clinical and radiographic evaluation.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Systemic conditions that could affect bone healing (e.g., uncontrolled diabetes, metabolic bone diseases).
  • History of radiotherapy or chemotherapy to the head and neck region.
  • Active sinus pathology or chronic sinusitis.
  • Heavy smoking (more than 10 cigarettes per day).
  • Pregnancy or lactation.
  • Use of medications known to affect bone metabolism.

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group
Patients received dental implant placement without sinus augmentation. Bone biopsy samples were obtained during implant placement for histological and immunohistochemical evaluation.
Procedure: Dental Implant Placement Without Sinus Augmentation
Dental implant placement was performed without sinus augmentation. Bone biopsy samples were obtained from the implant site during implant placement for histological and immunohistochemical evaluation.
Experimental: Allograft Group
Patients underwent lateral maxillary sinus augmentation using allograft material prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses.
Procedure: Lateral Maxillary Sinus Augmentation with Allograft
Lateral sinus floor elevation was performed using allograft material prior to dental implant placement.
Experimental: Xenograft Group
Patients underwent lateral maxillary sinus augmentation using xenograft material prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses.
Procedure: Lateral Maxillary Sinus Augmentation with Xenograft
Lateral sinus floor elevation was performed using xenograft material prior to dental implant placement.
Experimental: Combined Graft Group
Patients underwent lateral maxillary sinus augmentation using a combination of allograft and xenograft materials prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses.
Procedure: Lateral Maxillary Sinus Augmentation with Combined Graft
Lateral sinus floor elevation was performed using a combination of allograft and xenograft materials prior to dental implant placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertical Bone Height Gain
Time Frame: 6 months
Vertical bone height gain following lateral maxillary sinus augmentation, measured using cone-beam computed tomography (CBCT).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft Height Loss
Time Frame: 6 months
Change in grafted bone height between early postoperative and 6-month CBCT measurements.
6 months
Histological New Bone Formation
Time Frame: 6 months
Qualitative and semi-quantitative histological evaluation of new bone formation in bone biopsy samples obtained during implant placement.
6 months
Immunohistochemical Expression of Osteogenic Markers
Time Frame: 6 months
Immunohistochemical expression of osteocalcin, osteopontin, and RUNX2 in bone biopsy samples obtained from grafted sites.
6 months

Collaborators and Investigators

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

Sponsor

Tokat Gaziosmanpasa 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)

June 30, 2022

Primary Completion (Actual)

April 24, 2024

Study Completion (Actual)

April 24, 2024

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-KAEK-118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

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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