Teriparatide on Maxillary Sinus Floor Osseointegration

Universidad de Valparaiso

Status and phase: Enrolling; Phase 4

Conditions: Bone Regeneration

Treatments: Procedure: Dental Implant Installation; Combination Product: Bone graft; Procedure: Maxillary Sinus Augmentation; Drug: Teriparatide

Study type: Interventional

Funder types: Other

Identifiers

NCT06061354

CEC 256-22

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Teriparatide

Experimental group

Description:

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

Treatment:

Procedure: Maxillary Sinus Augmentation

Drug: Teriparatide

Combination Product: Bone graft

Procedure: Dental Implant Installation

Placebo

Placebo Comparator group

Description:

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

Treatment:

Procedure: Maxillary Sinus Augmentation

Combination Product: Bone graft

Procedure: Dental Implant Installation