RecruitingPhase 4NCT06338241

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


Sponsor

Mario Pérez Sayáns

Enrollment

30 participants

Start Date

Mar 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria6

  • Participants must be of legal age.
  • Participants must provide informed consent for participation in the study.
  • Participants must require extraction of both impacted mandibular third molars.
  • Both impacted molars must exhibit a similar level of complexity for extraction.
  • Participants must have no history of infection in the impacted molars prior to extraction.
  • Participants must not have any contraindications to undergoing oral surgical procedures (ASA I/II classification).

Exclusion Criteria4

  • Participants with severe mental disorders that may impair their ability to provide informed consent or follow study instructions.
  • Participants currently receiving medications contraindicated for dental extractions.
  • Participants under the age of legal consent.
  • Participants who have undergone head and neck radiotherapy within the past 18 months.

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Interventions

COMBINATION_PRODUCTBiphasic 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.

OTHERBovine 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.


Locations(2)

Faculty of Dentistry of Universidade de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Faculty of Dentistry University of Murcia

Murcia, Spain

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NCT06338241


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