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

NCT07407361 | Completed

• 1 other identifier: 22-KAEK-118
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posterior Maxillary Atrophy; Maxillary Sinus Augmentation

Keywords

Maxillary sinus augmentation; Bone grafts; Dental implants

Outcome Measures

Primary Outcomes (1)

• Vertical Bone Height Gain

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

  6 months

Secondary Outcomes (3)

• Graft Height Loss

  6 months

• Histological New Bone Formation

  6 months

• Immunohistochemical Expression of Osteogenic Markers

  6 months

Study Arms (4)

Control Group

EXPERIMENTAL

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

Allograft Group

EXPERIMENTAL

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

Xenograft Group

EXPERIMENTAL

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

Combined Graft Group

EXPERIMENTAL

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

Interventions

Lateral Maxillary Sinus Augmentation with Allograft PROCEDURE

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

Allograft Group

Lateral Maxillary Sinus Augmentation with Xenograft PROCEDURE

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

Xenograft Group

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.

Combined Graft Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpaşa University Faculty of Dentistry

Tokat Province, Tokat Province, 60230, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Transplantation, Homologous; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Histological and immunohistochemical evaluations were performed by a blinded examiner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: June 30, 2022
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)