An interventional study of Deproteinized Bovine Bone Mineral (Bio-Oss) and Deproteinized Bovine Bone Mineral (InterOss) in Alveolar Bone Loss, Sinus Floor Augmentation and Edentulous Alveolar Ridge, sponsored by Universidad del Desarrollo. Recruiting at 1 site in Chile. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Universidad del Desarrollo · Not applicable, Interventional, and Treatment
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:
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:
Background and rationale
After loss of posterior maxillary teeth, alveolar bone resorption combined with pneumatization of the maxillary sinus frequently leaves insufficient bone height for implant placement. Lateral window sinus floor augmentation is a well-documented and predictable procedure to restore this bone volume. Deproteinized bovine bone mineral (DBBM) is widely used as a graft material because of its osteoconductive properties and slow resorption, which help maintain the augmented space during bone formation. Bio-Oss is the most studied DBBM and is considered a reference material. InterOss is a DBBM with comparable physicochemical characteristics (particle size, morphology, and meso- and microporosity), but clinical and histological evidence comparing both materials in sinus augmentation is limited.
Adding autogenous bone to DBBM has been associated with a higher proportion of vital bone in sinus biopsies, likely due to its osteoprogenitor cell content, but autogenous bone harvesting adds donor-site morbidity. Bone marrow stromal cells can be isolated from the maxilla and mandible, and orofacial marrow cells have shown osteogenic and angiogenic potential comparable to or greater than iliac crest cells. Small-volume aspiration of mandibular marrow blood is a minimally invasive way to deliver these cells to the graft. This trial evaluates whether mixing DBBM with mandibular marrow blood increases vital bone formation, and whether InterOss performs comparably to Bio-Oss.
Study design
Randomized clinical trial with a 2x2 factorial design (graft material: Bio-Oss vs. InterOss; with vs. without mandibular marrow blood), conducted at the Postgraduate Program in Oral and Maxillofacial Implantology, Faculty of Medicine, Clínica Alemana - Universidad del Desarrollo, Santiago, Chile. The unit of analysis is the augmented sinus. Allocation is generated with a computer-generated random sequence (Microsoft Excel). In bilateral cases, each sinus is allocated to a different group. Surgeons are not blinded, as the marrow aspiration procedure is evident. The radiographic examiner and the pathologist performing histomorphometry are blinded to group allocation. Sample size was estimated in G*Power based on vital bone proportions reported in a previous sinus augmentation trial comparing two DBBMs, resulting in 10 sinuses per group (40 sinuses in total).
Surgical procedure (stage 1)
Under local anesthesia (2% lidocaine with 1:100,000 epinephrine), a full-thickness flap with a palatalized crestal incision and releasing incisions is raised. A lateral bony window is prepared with piezoelectric surgery, and the Schneiderian membrane is elevated with sinus curettes. The sinus is filled with approximately 1 to 1.5 g of large-particle (1-2 mm) DBBM according to group allocation. Membrane perforations are covered with a resorbable collagen membrane. Primary tension-free closure is achieved with 5-0 nylon sutures. Patients receive antibiotic prophylaxis (amoxicillin/clavulanic acid) and postoperative analgesia, with follow-up at 1 week and suture removal at 14 days.
Mandibular marrow blood harvesting
In the marrow blood groups, a modified University of Michigan protocol is followed. Through a small full-thickness flap in the retromolar/external oblique ridge area, the cortical bone is perforated to a depth of 4-5 mm 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 DBBM immediately before grafting.
Implant placement and biopsy (stage 2)
Eight months after sinus augmentation, a control cone beam CT (CBCT) is obtained for implant planning and radiographic assessment. During implant placement, a bone core is harvested from the grafted area with a trephine bur (2.3 mm inner / 3.0 mm outer diameter) in a coronal-to-apical direction through the residual crest, approximately 7 mm deep.
Histomorphometric analysis
Specimens are fixed in formalin, decalcified in 5% formic acid for 10 days, embedded in paraffin, and sectioned along the long axis of the core. The two most central sections are stained with hematoxylin-eosin and analyzed under light microscopy. The proportions of vital new bone, residual graft particles, connective/fibrovascular tissue, and total bone (vital bone plus graft) are calculated relative to the total sample area.
Radiographic analysis
Preoperative and 8-month CBCT scans are analyzed in DICOM format with BlueSky Plan software. Residual and augmented bone heights are measured in sagittal and coronal views, each as the mean of three slices 1 mm apart. Sinus health and ostium patency are also assessed. Examiners are trained and calibrated beforehand (kappa index).
Rehabilitation and follow-up
Implants are restored approximately 6 months after placement. Patients are followed annually with clinical examination and CBCT.
Statistical analysis
Normality is assessed with the Shapiro-Wilk test. Histomorphometric results are expressed as percentages and radiographic measurements in millimeters. Categorical variables are compared with the chi-square test. Associations between variables are assessed with multiple linear or logistic regression as appropriate. Statistical significance is set at p \< 0.05.
318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.
This study's planned enrollment of 40 is above the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Universidad del Desarrollo is the lead sponsor of 24 studies on the registry; 8 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Deproteinized Bovine Bone Mineral (Bio-Oss)
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.
Device: Deproteinized Bovine Bone Mineral (InterOss)
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.
Device: Deproteinized Bovine Bone Mineral (Bio-Oss) · Procedure: Mandibular Bone Marrow Blood Aspiration
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.
Device: Deproteinized Bovine Bone Mineral (InterOss) · Procedure: Mandibular Bone Marrow Blood Aspiration
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, 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.
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.
Time frame: 8 months after sinus augmentation
Percentage of Residual Graft Particles
Proportion of the total biopsy area occupied by residual xenograft particles (%GP), measured by histomorphometry on hematoxylin-eosin stained sections of the bone core harvested at implant placement, by a pathologist blinded to group allocation.
Time frame: 8 months after sinus augmentation
Percentage of Connective Tissue
Proportion of the total biopsy area occupied by connective/fibrovascular tissue (%CT), measured by histomorphometry on hematoxylin-eosin stained sections of the bone core harvested at implant placement, by a pathologist blinded to group allocation.
Time frame: 8 months after sinus augmentation
Percentage of Total Bone
Proportion of the total biopsy area occupied by vital bone plus residual graft particles (%TB), measured by histomorphometry on hematoxylin-eosin stained sections of the bone core harvested at implant placement, by a pathologist blinded to group allocation.
Time frame: 8 months after sinus augmentation
Radiographic Bone Height Gain (Sagittal View)
Difference between augmented bone height (ARRSI) and residual alveolar ridge height (ARRS), in millimeters, measured on sagittal CBCT slices with BlueSky Plan software. Each value is the mean of three slices 1 mm apart. Measurements are performed by a calibrated examiner blinded to group allocation.
Time frame: Baseline (preoperative) and 8 months after sinus augmentation
Radiographic Bone Height Gain (Coronal View)
Difference between augmented bone height (ARRCI) and residual alveolar ridge height (ARRC), in millimeters, measured on coronal CBCT slices with BlueSky Plan software. Each value is the mean of three slices 1 mm apart. Measurements are performed by a calibrated examiner blinded to group allocation.
Time frame: Baseline (preoperative) and 8 months after sinus augmentation
Plan to share: No — 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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