Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

April 30, 2025

Study Completion Date

September 30, 2025

Conditions
Bone AtrophyEdentulismBone Regeneration
Interventions
DEVICE

Placement of resorbable HAp-based composite

The resorbable HAp-based composite device will be immersed in a saline solution for 15 minutes, allowing it to transition from a rigid state to a flexible and deformable one (Fig. 1). Subsequently, the device will be shaped appropriately on the resin model, ensuring proper placement within the bone defect to be regenerated. Patients will receive antibiotic prophylaxis of 1 g amoxicillin, 1 hour before the procedure (or 300 mg clindamycin in case of penicillin allergy). Before the surgical procedure, patients will rinse with 2% chlorhexidine for one minute to reduce the bacterial load in the oral cavity. For the surgical procedure, under local anesthesia with Articaine and Adrenaline 1:100000, mucoperiosteal flaps will be raised. The pre-shaped resorbable device will then be adapted to the defect and fixed with osteosynthesis screws, used according to clinical practice for this type of intervention. Finally, the flaps will be sutured to ensure primary intention closure.

Trial Locations (1)

40125

Dental Clinic, Unit of Oral Surgery, University of Bologna, Bologna

All Listed Sponsors
lead

University of Bologna

OTHER

NCT06552715 - Pilot Study on the Effectiveness of a Flexible Hydroxyapatite-Based Composite for Jaw Bone Regeneration | Biotech Hunter | Biotech Hunter