Teriparatide on Maxillary Sinus Floor Osseointegration

NCT06061354 | Unknown Phase 4 FDA Device

• 1 other identifier: CEC 256-22
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Regeneration

Keywords

teriparatide; Bio-Oss®; bone graft; dental implants; maxillary sinus augmentation; bone regeneration

Outcome Measures

Primary Outcomes (1)

• Histology

  osteoblasts/mm2

  3 months

Secondary Outcomes (1)

• Histomorphometry

  3 months

Other Outcomes (2)

• implant stability coefficient (ISQ)

  6 months

• Bone Level

  6 months

Study Arms (2)

Teriparatide

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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

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

Interventions

Teriparatide DRUG

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.

Also known as: Teriparatide Pen Injector [Forteo]

Teriparatide

Maxillary Sinus Augmentation PROCEDURE

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.

Placebo; Teriparatide

Dental Implant Installation PROCEDURE

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.

Placebo; Teriparatide

Bone graft COMBINATION_PRODUCT

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.

Also known as: Bio-Oss®

Placebo; Teriparatide

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Valparaiso: lead
• Universidade Federal Fluminense: collaborator

Study Sites (1)

Facultad de Odontología, Universidad de Valparaiso

Valparaíso, Región de Valparaíso, 2360004, Chile

RECRUITING

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MeSH Terms

Interventions

Teriparatide; Sinus Floor Augmentation; Bone Transplantation; Bio-Oss

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Oral Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Dentistry; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation

Study Officials

• Rafael Seabra Louro, DDS,MSc,PhD

  Universidade Federal Fluminense

  STUDY DIRECTOR

Central Study Contacts

Jessika Dethlefs, DDS, MSc

CONTACT

+56993231103; jessika.dethlefs@uv.cl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 29, 2023
• Study Start: August 23, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

CL (1)