Teriparatide on Maxillary Sinus Floor Osseointegration

Bone Regeneration Clinical Trial

Official title:

Bone Microarchitecture and Implant Stabilization in Atrophic Jaws Reconstructed With Bone Grafts Treated With Teriparatide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061354
• Other study ID #: CEC 256-22
• Status: Recruiting
• Phase: Phase 4
• Start date: August 23, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Universidad de Valparaiso
• Contact: Jessika Dethlefs, DDS, MSc
• Phone: +56993231103
• Email: jessika.dethlefs[@]uv.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Pneumatization of a maxillary sinus with a residual ridge = 5 mm in height (according to baseline conebeam tomograph).
• Must sign an informed consent to participate in this study.

Exclusion Criteria:

• Residual ridges less than 4 mm in height.
• 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.

Related Conditions & MeSH terms

• Bone Regeneration

Intervention

Drug:
• 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.

Procedure:
• 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.

Combination Product:
• 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.

Locations

Country	Name	City	State
Chile	Facultad de Odontología, Universidad de Valparaiso	Valparaíso	Valparaiso

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Universidade Federal Fluminense

Country where clinical trial is conducted

Chile, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	6 months
Other	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
Primary	Histology	osteoblasts/mm2	3 months
Secondary	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