Teriparatide on Maxillary Sinus Floor Osseointegration

PHASE4RecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

August 23, 2023

Primary Completion Date

August 31, 2024

Study Completion Date

December 31, 2024

Conditions
Bone Regeneration
Interventions
DRUG

Teriparatide

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.

PROCEDURE

Maxillary Sinus Augmentation

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.

PROCEDURE

Dental Implant Installation

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.

COMBINATION_PRODUCT

Bone graft

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.

Trial Locations (1)

2360004

RECRUITING

Facultad de Odontología, Universidad de Valparaiso, Valparaíso

All Listed Sponsors
collaborator

Universidade Federal Fluminense

OTHER

lead

Universidad de Valparaiso

OTHER