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
Location: See all (2) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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• 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).

Locations
Other Locations
Spain
Faculty of Dentistry University of Murcia
RECRUITING
Murcia
Faculty of Dentistry of Universidade de Santiago de Compostela
RECRUITING
Santiago De Compostela
Contact Information
Primary
MARIO PEREZ SAYANS GARCIA, PHD, PHD
mario.perez@usc.es
+34626233504
Time Frame
Start Date: 2024-03-02
Estimated Completion Date: 2025-09-02
Participants
Target number of participants: 30
Treatments
Experimental: Galibone Group
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.
Active_comparator: Control group
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.
Related Therapeutic Areas
Sponsors
Leads: Mario Pérez Sayáns
Collaborators: Universidad de Murcia

This content was sourced from clinicaltrials.gov