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NCT06061354 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

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Study Design

Related Conditions & MeSH terms

Intervention

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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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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
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