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

Mario Pérez Sayáns

Status and phase: Enrolling; Phase 4

Conditions: Regenerative Inflammation; Bone Loss

Treatments: Other: Bovine Hydroxyapatite; Combination Product: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06338241

CPP2021-008391

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Galibone Group

Experimental group

Description:

The Galibone+ experimental group includes participants receiving Galibone+ after impacted mandibular third molar extraction, testing its osteogenic properties. Galibone+ is prepared per manufacturer's instructions, potentially by immersing in sterile saline. Applied post-extraction into the socket using specialized instruments, it's compared to a control group receiving Bio-Oss, a standard xenograft material. Experimental group patients receive postoperative medications, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation. Goal: Assess Galibone+'s efficacy in bone regeneration versus control.

Treatment:

Combination Product: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin

Control group

Active Comparator group

Description:

The control group serves as an active comparator to the Galibone+ experimental group in this study. Participants undergo identical impacted mandibular third molar extraction procedures as the experimental group but receive a standard material, likely Bio-Oss, instead of Galibone+. Bio-Oss, a widely used xenograft material in dental surgeries, acts as a benchmark due to its osteoconductive properties. Applied post-extraction into the socket with specialized instruments, it provides a reference for comparing Galibone+'s efficacy. Patients in the control group receive postoperative medications as per the study protocol, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation.

Treatment:

Other: Bovine Hydroxyapatite