Maxillary Sinus Augmentation, Posterior Maxillary Atrophy
Conditions
Keywords
Maxillary sinus augmentation, Bone grafts, Dental implants
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.
Interventions
PROCEDURELateral Maxillary Sinus Augmentation with Allograft
Lateral sinus floor elevation was performed using allograft material prior to dental implant placement.
PROCEDURELateral Maxillary Sinus Augmentation with Xenograft
Lateral sinus floor elevation was performed using xenograft material prior to dental implant placement.
PROCEDURELateral 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.
PROCEDUREDental 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.
Sponsors
Tokat Gaziosmanpasa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Histological and immunohistochemical evaluations were performed by a blinded examiner.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertical Bone Height Gain | 6 months | Vertical bone height gain following lateral maxillary sinus augmentation, measured using cone-beam computed tomography (CBCT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft Height Loss | 6 months | Change in grafted bone height between early postoperative and 6-month CBCT measurements. |
| Histological New Bone Formation | 6 months | Qualitative and semi-quantitative histological evaluation of new bone formation in bone biopsy samples obtained during implant placement. |
| Immunohistochemical Expression of Osteogenic Markers | 6 months | Immunohistochemical expression of osteocalcin, osteopontin, and RUNX2 in bone biopsy samples obtained from grafted sites. |
Countries
Turkey (Türkiye)
Outcome results
None listed