NCT06338241

Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model

Clinical Study to Analyze the Osteogenic Action of a Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model (Galibone+) in Bone Regeneration Following the Extraction of Impacted Mandibular Third Molars

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mario Pérez Sayáns · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars.

Detailed description

With a focus on both clinical and radiological outcomes, the study seeks to compare the efficacy of Galibone+ against a standard material (Bio-Oss) through a double-blind, randomized split-mouth trial involving 30 patients. Variables including pain, inflammation, and post-surgical complications will be monitored during the initial seven-day follow-up, while bone volume reduction and mineral density will be evaluated radiographically over a six-month period. The study's findings promise to shed light on the potential of Galibone+ as a promising adjunct in enhancing bone regeneration following dental extractions, thereby advancing oral surgical practices and patient outcomes.

Conditions

• Bone Loss
• Regenerative Inflammation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin	The intervention description for Galibone+ in the study involves the application of this substance to promote bone regeneration following the extraction of impacted mandibular third molars. Galibone is indicated to treat segmental and cavity bone loss, aesthetic repairs and bone augmentations (such as inlay or onlay grafts); to fill dental alveolar bone; for the placement of dental implants; for the stabilization of osteotomies and prostheses in dentistry.
OTHER	Bovine Hydroxyapatite	The intervention description for Bio-Oss in the study involves the application of this standard material to promote bone regeneration following the extraction of impacted mandibular third molars. Bio-Oss is a commonly used xenograft material known for its osteoconductive properties.

Timeline

• Start date: 2024-03-02
• Primary completion: 2025-06-02
• Completion: 2025-09-02
• First posted: 2024-03-29
• Last updated: 2024-04-03

Locations

2 sites across 1 country: Spain