Clinical trial NCT06061354: Teriparatide on Maxillary Sinus Floor Osseointegration
Official title: Bone Microarchitecture and Implant Stabilization in Atrophic Jaws Reconstructed With Bone Grafts Treated With Teriparatide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bone Regeneration
Keywords: teriparatide
Bio-Oss®
bone graft
dental implants
maxillary sinus augmentation
bone regeneration
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Universidade Federal Fluminense
First posted: 2023-09-29
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Histology
timeFrame: 3 months
Secondary outcomes:
measure: Histomorphometry
timeFrame: 3 months
Other outcomes:
measure: implant stability coefficient (ISQ)
timeFrame: 6 months
measure: Bone Level
timeFrame: 6 months
Locations:
city: Valparaíso
country: Chile
facility: Facultad de Odontología, Universidad de Valparaiso
state: Valparaiso
Study officials:
affiliation: Universidade Federal Fluminense
name: Rafael Seabra Louro, DDS,MSc,PhD
role: STUDY_DIRECTOR
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