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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
Sponsor study identifier
interventional
40
1 country
1
Study Start
June 1, 2023
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2023
Actual (reported)October 22, 2026
Actual (reported)October 29, 2026
Actual (reported)March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage of New Vital Bone in the Augmented Sinus
Proportion of the total area of the bone core biopsy occupied by newly formed vital bone (%NB = vital bone area / total sample area x 100), measured by histomorphometry on the two most central hematoxylin-eosin stained sections of a trephine core (2.3 mm inner diameter, approximately 7 mm long) harvested from the grafted area at implant placement. Analysis is performed under light microscopy by a pathologist blinded to group allocation.
8 months after sinus augmentation
Percentage of Residual Graft Particles
8 months after sinus augmentation
Percentage of Connective Tissue
8 months after sinus augmentation
Lateral window maxillary sinus floor augmentation with Bio-Oss (deproteinized bovine bone mineral, large particles 1-2 mm) alone, approximately 1-1.5 g per sinus. Implants are placed 8 months later, when a bone core biopsy is obtained from the grafted area.
Lateral window maxillary sinus floor augmentation with InterOss (deproteinized bovine bone mineral, large particles 1-2 mm) alone, approximately 1-1.5 g per sinus. Implants are placed 8 months later, when a bone core biopsy is obtained from the grafted area.
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.
Universidad del Desarrollo (UDD)
Santiago, Santiago Metropolitan, 7610315, Chile
Akintoye SO, Lam T, Shi S, Brahim J, Collins MT, Robey PG. Skeletal site-specific characterization of orofacial and iliac crest human bone marrow stromal cells in same individuals. Bone. 2006 Jun;38(6):758-68. doi: 10.1016/j.bone.2005.10.027. Epub 2006 Jan 3.
Akintoye SO, Giavis P, Stefanik D, Levin L, Mante FK. Comparative osteogenesis of maxilla and iliac crest human bone marrow stromal cells attached to oxidized titanium: a pilot study. Clin Oral Implants Res. 2008 Nov;19(11):1197-201. doi: 10.1111/j.1600-0501.2008.01592.x.
Claudio M Miranda, DDS
Universidad del Desarrollo
Francisca c Collao, DDS
Universidad del Desarrollo
Dusan M Marinkovic, DDS
Universidad del Desarrollo
First Submitted
October 22, 2026
First Posted
October 29, 2026
Percentage of Total Bone
8 months after sinus augmentation
Radiographic Bone Height Gain (Sagittal View)
Baseline (preoperative) and 8 months after sinus augmentation
Radiographic Bone Height Gain (Coronal View)
Baseline (preoperative) and 8 months after sinus augmentation
Lateral window maxillary sinus floor augmentation with Bio-Oss (large particles 1-2 mm) mixed with approximately 0.5 mL of autologous marrow blood aspirated from the mandibular retromolar/external oblique ridge area (modified University of Michigan protocol), approximately 1-1.5 g of graft per sinus. Implants are placed 8 months later, when a bone core biopsy is obtained from the grafted area.
Lateral window maxillary sinus floor augmentation with InterOss (large particles 1-2 mm) mixed with approximately 0.5 mL of autologous marrow blood aspirated from the mandibular retromolar/external oblique ridge area (modified University of Michigan protocol), approximately 1-1.5 g of graft per sinus. Implants are placed 8 months later, when a bone core biopsy is obtained from the grafted area.
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.
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.
Contact the study team to confirm eligibility.
Mason S, Tarle SA, Osibin W, Kinfu Y, Kaigler D. Standardization and safety of alveolar bone-derived stem cell isolation. J Dent Res. 2014 Jan;93(1):55-61. doi: 10.1177/0022034513510530. Epub 2013 Oct 29.
da Silva HF, Goulart DR, Sverzut AT, Olate S, de Moraes M. Comparison of two anorganic bovine bone in maxillary sinus lift: a split-mouth study with clinical, radiographical, and histomorphometrical analysis. Int J Implant Dent. 2020 May 6;6(1):17. doi: 10.1186/s40729-020-00214-w.
Study Start
June 1, 2023
Actual (reported)Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Individual participant data will not be shared due to the small sample size and the risk of participant re-identification. Aggregated results will be reported in publications.
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Source: ClinicalTrials.gov.
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