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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Combination product
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 70
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Chile
Facultad de Odontología, Universidad de Valparaiso
RECRUITING
Valparaíso
Contact Information
Primary
Jessika Dethlefs, DDS, MSc
jessika.dethlefs@uv.cl
+56993231103
Time Frame
Start Date: 2023-08-23
Estimated Completion Date: 2024-12
Participants
Target number of participants: 42
Treatments
Experimental: 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
Placebo_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Universidad de Valparaiso
Collaborators: Universidade Federal Fluminense

This content was sourced from clinicaltrials.gov