Study Results
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Basic Information
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RECRUITING
PHASE4
42 participants
INTERVENTIONAL
2023-08-23
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Teriparatide
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
Teriparatide
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.
Maxillary Sinus Augmentation
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
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
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.
Placebo
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
Maxillary Sinus Augmentation
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
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
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.
Interventions
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Teriparatide
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.
Maxillary Sinus Augmentation
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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must sign an informed consent to participate in this study.
Exclusion Criteria
* Uncontrolled systemic disease (ASA 3, 4, 5, and 6)
* Presenting with osteoporosis or any disease of bone metabolism.
* Having received radiotherapy.
* Cancer.
* Any systemic condition that affects calcium absorption.
* Kidney disease.
* Coagulation disorders.
* History of sinusitis.
* Maxillary sinus pathology.
* Heavy smoking (\> 1 pack per day).
* Drug or alcohol users.
* Pregnancy.
* Treatment with drugs that affect bone metabolism.
* Treatment with immunosuppressants.
* Allergies.
* Uncontrolled periodontal pathology.
* Tooth extractions in the last three months.
25 Years
70 Years
ALL
Yes
Sponsors
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Universidade Federal Fluminense
OTHER
Universidad de Valparaiso
OTHER
Responsible Party
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Principal Investigators
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Rafael Seabra Louro, DDS,MSc,PhD
Role: STUDY_DIRECTOR
Universidade Federal Fluminense
Locations
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Facultad de Odontología, Universidad de Valparaiso
Valparaíso, Región de Valparaíso, Chile
Countries
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Central Contacts
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Facility Contacts
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Jessika Dethlefs, DDS, MSc
Role: primary
Solange Baeza, DDS, Msc
Role: backup
References
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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CEC 256-22
Identifier Type: -
Identifier Source: org_study_id