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NCT Number: NCT07407361

Comparison of Allograft, Xenograft and Combined Grafting in Maxillary Sinus Augmentation

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.

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Key information

Conditions

Posterior Maxillary Atrophy Maxillary Sinus Augmentation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpaşa University Faculty of Dentistry

Tokat Province, 60230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lateral Maxillary Sinus Augmentation with Allograft

Procedure

Lateral sinus floor elevation was performed using allograft material prior to dental implant placement.

Lateral Maxillary Sinus Augmentation with Xenograft

Procedure

Lateral sinus floor elevation was performed using xenograft material prior to dental implant placement.

Lateral Maxillary Sinus Augmentation with Combined Graft

Procedure

Lateral sinus floor elevation was performed using a combination of allograft and xenograft materials prior to dental implant placement.

Dental Implant Placement Without Sinus Augmentation

Procedure

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.

Primary outcomes

  1. Vertical Bone Height Gain

    Time frame: 6 months

    Vertical bone height gain following lateral maxillary sinus augmentation, measured using cone-beam computed tomography (CBCT).

Secondary outcomes

  1. Graft Height Loss

    Time frame: 6 months

    Change in grafted bone height between early postoperative and 6-month CBCT measurements.

  2. 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.

  3. Immunohistochemical Expression of Osteogenic Markers

    Time frame: 6 months

    Immunohistochemical expression of osteocalcin, osteopontin, and RUNX2 in bone biopsy samples obtained from grafted sites.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Acronym: SINUS-GRAFT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2026
Registry last updated
Feb 12, 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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