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| Name | Class |
|---|---|
| Universidade Federal Fluminense | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histology | osteoblasts/mm2 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessika Dethlefs, DDS, MSc | Contact | +56993231103 | jessika.dethlefs@uv.cl |
| Name | Affiliation | Role |
|---|---|---|
| Rafael Seabra Louro, DDS,MSc,PhD | Universidade Federal Fluminense | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de OdontologÃa, Universidad de Valparaiso | Recruiting | ValparaÃso | Valparaiso | 2360004 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9240383 | Background | Miller SC, Hunziker J, Mecham M, Wronski TJ. Intermittent parathyroid hormone administration stimulates bone formation in the mandibles of aged ovariectomized rats. J Dent Res. 1997 Aug;76(8):1471-6. doi: 10.1177/00220345970760080901. | |
| 15515341 | Background | Boabaid F, Berry JE, Koh AJ, Somerman MJ, McCcauley LK. The role of parathyroid hormone-related protein in the regulation of osteoclastogenesis by cementoblasts. J Periodontol. 2004 Sep;75(9):1247-54. doi: 10.1902/jop.2004.75.9.1247. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2023 | Sep 20, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 28, 2023 | Sep 7, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D059546 | Sinus Floor Augmentation |
| D016025 | Bone Transplantation |
| C077540 | Bio-Oss |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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|
| Maxillary Sinus Augmentation | Procedure | 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. |
|
| Dental Implant Installation | Procedure | 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. |
|
| Bone graft | Combination Product | 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. |
|
|
| 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. | 6 months |
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| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019637 | Orthopedic Procedures |
| D003813 | Dentistry |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |