Teriparatide on Maxillary Sinus Floor Osseointegration

What Was Tested

This registered phase 4 trial tested Teriparatide.

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.

It had two arms (groups): Teriparatide (experimental) and 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 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.

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.

The registry classes the interventions as combination product, drug and procedure.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to people of any sex aged from 25 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 2 inclusion and 18 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

The Teriparatide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Teriparatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-08-23 with completion listed for 2024-08.

It ran at 1 site in Chile.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Histology (time frame: 3 months).

It also tracked 1 secondary outcome, for example Histomorphometry.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Teriparatide in 42 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.