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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Sponsor: Universidad del Desarrollo
Summary
The goal of this clinical trial is to learn whether adding a small amount of blood taken from the jawbone marrow improves new bone formation when two different bone graft materials are used in maxillary sinus lift surgery. The study includes adults aged 25 to 65 who need more bone height in the upper back jaw before receiving dental implants. The main questions it aims to answer are: * Does InterOss (a bovine bone graft material) form a similar amount of new living bone as Bio-Oss (a widely used bovine bone graft material)? * Does mixing either graft material with bone marrow blood from the lower jaw increase the amount of new living bone and the bone height gained? Researchers will compare four groups: Bio-Oss alone, InterOss alone, Bio-Oss mixed with jawbone marrow blood, and InterOss mixed with jawbone marrow blood. Each treated sinus is randomly assigned to one group. Patients treated on both sides receive a different treatment on each side. Participants will: * Have a sinus lift surgery through a small side window in the upper jaw, where the sinus floor is filled with the assigned graft material. In two of the groups, a small amount of marrow blood (about 0.5 mL) will be drawn from the lower jaw and mixed with the graft. * Have a 3D dental X-ray (cone beam CT) before surgery and 8 months after surgery to measure the bone height gained. * Have dental implants placed 8 months after the sinus lift. During this surgery, a small bone sample will be taken from the grafted area and examined under a microscope. * Receive their implant-supported teeth about 6 months later and attend yearly check-up visits with a clinical exam and X-rays.
Official title: Comparison of Two Anorganic Xenografts in the Lateral Window Maxillary Sinus Augmentation Technique With or Without Mandibular Bone Marrow Blood Admixture: Histomorphometric, Radiographic and Clinical Analysis
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-06-01
Completion Date
2028-01-01
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
Deproteinized Bovine Bone Mineral (Bio-Oss)
Deproteinized bovine bone mineral, large particle size (1-2 mm granules), manufactured by Geistlich Pharma AG (Wolhusen, Switzerland). Approximately 1-1.5 g is placed in the maxillary sinus after elevation of the Schneiderian membrane through a lateral window prepared with piezoelectric surgery. Used alone or mixed with mandibular marrow blood depending on the assigned arm. Reference (control) graft material.
Deproteinized Bovine Bone Mineral (InterOss)
Deproteinized bovine bone mineral, large particle size (1-2 mm granules), manufactured by SigmaGraft Biomaterials (Fullerton, CA, USA). Approximately 1-1.5 g is placed in the maxillary sinus after elevation of the Schneiderian membrane through a lateral window prepared with piezoelectric surgery. Used alone or mixed with mandibular marrow blood depending on the assigned arm. Test graft material with physicochemical characteristics similar to Bio-Oss.
Mandibular Bone Marrow Blood Aspiration
Autologous bone marrow blood harvesting following a modified University of Michigan protocol. Through a small full-thickness flap in the retromolar/external oblique ridge area, the mandibular cortex is perforated 4-5 mm deep with a round carbide bur to reach the medullary space. Approximately 0.5 mL of marrow blood is aspirated with a heparinized 21G catheter and syringe, collected in a heparinized container, and mixed with the bovine bone graft immediately before placement in the sinus. No cell processing or culture is performed.
Locations (1)
Universidad del Desarrollo (UDD)
Santiago, Santiago Metropolitan, Chile