A Phase 4 interventional study of Teriparatide and Maxillary Sinus Augmentation in Bone Regeneration, sponsored by Universidad de Valparaiso. Recruiting at 1 site in Chile. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Universidad de Valparaiso · Phase 4, Interventional, and Treatment
The aim of this triple blind randomized controlled trial will be to analyze the effect of a dose of teriparatide combined with a xenograft on bone augmentation of the maxillary sinus, to observe the microarchitecture of the newly formed bone and the primary and late stability of implants placed on these grafts. The sample is composed of 42 participants who have a clinical indication for maxillary sinus floor augmentation with bone grafting due to residual bone height less than or equal to 5mm for the installation of dental implants. Each side will be grafted with Bio-Oss® or Bio-Oss® combined with 1 dose (20 µg) of teriparatide (Forteo®). Three months after grafting, at the time of placement of dental implants, bone biopsies will be obtained using a short 2mm trephine bur. These bone cores will be submitted to histological and histomorphometric analysis. The stability of the implants will be measured, at the time of their installation, through the insertion torque, and through the use of resonance frequency equipment (Ostell®) in three moments: immediately and at 3 and 6 months after the installation of the dental implants.
Universidad de Valparaiso is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
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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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material Bio-Oss® mixed with Forteo® will be delivered for placement on the sinus floor maxilla below Schneider's membrane. Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
Drug: Teriparatide · Procedure: Maxillary Sinus Augmentation · Procedure: Dental Implant Installation · Combination Product: Bone graft
Access to the maxillary sinus will be done through osteotomy, using a piezosurgery . Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material, Bio-Oss® mixed with saline solution, will be delivered for placement on the sinus floor maxilla below Schneider's membrane. Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed
Procedure: Maxillary Sinus Augmentation · Procedure: Dental Implant Installation · Combination Product: Bone graft
mixture of 20μg of teriparatide, 0.64ml of saline solution with 1g of Bio -Oss® or 1g of Bio-Oss® will be mixed with 0.72ml of saline solution.
Also known as: Teriparatide Pen Injector [Forteo]
Local anesthesia will be performed, mucoperiosteal flap will be raised to access the anterior wall of the maxillary sinus. Access to the maxillary sinus will be done through osteotomy, using a piezosurgery under irrigation with saline solution. Subsequently, the Schneider's membrane will be carefully lifted and, according to the randomization process, the graft material (Bio-Oss® mixed with saline solution or Bio-Oss® mixed with Forteo®) will be delivered for placement on the sinus floor maxilla below Schneider's membrane.Next, the access window to the maxillary sinus and Schneider's membrane will be protected. The mucoperiosteal flap will be repositioned and closed.
Local anesthesia will be performed a mucoperiosteal flap will be raised in the area for implant placement and a bone core 10 mm high and 2 mm in diameter will be removed with a 2 mm trephine bur. The bone biopsied through this nucleus is part of the region where the implant will be installed, and the height of the sample depends on the surgical planning carried out previously (3-month radiographic control). The sequence of drills to place the implant will continue, installation of the implant itself and, finally, verification of the insertion torque and measurement of the resonance frequency in the already installed implant. The mucoperiosteal flap must be repositioned and sutured.
One arm:mixture of 20μg of teriparatide, 0.64ml of saline solution with 1g of Bio -Oss® In other arm: 1g of Bio-Oss® will be mixed with 0.72ml of saline solution.
Also known as: Bio-Oss®
Histology
osteoblasts/mm2
Time frame: 3 months
Histomorphometry
Describe de presence of following parameters: necrosis, inflammation, vascularization and angiogenesis, fibrosis, presence of medullary adipose tissue, new bone formation and foreign body reaction
Time frame: 3 months
implant stability coefficient (ISQ)
The implant stability coefficient (ISQ) will be evaluated by measuring the resonance frequency and the insertion torque at the time of implant installation. The implanted stability value, evaluated will be measured in two mutually perpendicular directions (distal mesio and palatine bucal). The scale goes from 1 to 100, where higher values indicate greater stability. The acceptable stability range is between 55 and 85 ISQ
Time frame: 6 months
Bone Level
Be evaluated using cone beam tomography images, using linear measurement in milimeter (mm) of the floor of the maxillary sinus and should include from the lowest point of the alveolar process to the most superior radiopaque point of the floor of the maxillary sinus exactly in the region where the grafts will be performed and later the installation of the implants.
Time frame: 6 months
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Studies of the drug tested here: Teriparatide
Universidad de Valparaiso