Safety and Efficacy Evaluation of the Ivory Dentin Graft Device

Launched by IVORY GRAFT LTD. · May 9, 2017

Keywords

ClinConnect Summary

Device Description - Investigational Medicinal Product Ivory Dentin Graft is a bone graft material for the repair or augmentation of bone defects in dental procedures. It consists of sterile 300 - 900 μm porous particles of hydroxyapatite which retain the natural form of the source porcine dentin.

Ivory Dentin Graft is intended to be used as a bone graft material for the repair or augmentation of bone defects in dental procedures.

OsteoBiol Gen Os. - Comparator control device A natural replicate of autologous bone, Gen-Os® conserves the same intimate structures (matrix and porous form) an...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patient 18 up to 80 years.
• • 2. Patient requiring at least one implant placement following mandibular pre-molar or molar tooth extraction.
• 3. Alveolar mandibular ridge (empty socket):
• • Height: not less than 10 mm, from the gingival margin to the mandibular nerve canal - as seen in the screening CT scan.
• • Width: not less than 5 mm, from buccal to lingual cortical plates - as seen in the screening CT scan.
• • 4. Ability to give informed consent for the study by patient or legal guardian.
• • 5. Willingness to undergo all follow up visits, as well as unscheduled sick visits.
• Exclusion Criteria:
• • 6. Pregnancy (all women of child-bearing age would be questioned and told by the consenting physician regarding that criteria).
• • 7. Known or suspected hypersensitivity to the constituents of the bone graft material (for example porcine collagen)
• • 8. Pathologies or conditions contraindicating surgery or presenting with active acute or chronic infections excluding periapical granuloma (for example osteomyelitis, sinusitis), uncontrolled diabetes
• • 9. Immunologic disorders or auto-immune pathologies, in particular elderly
• • 10. Serious bone diseases of endocrine aetiology
• • 11. Serious disturbances of bone metabolism
• • 12. Ongoing treatment with gluco- or mineralocorticoids, or with agents affecting calcium metabolism (e.g. calcitonin, bisphosphonates)
• • 13. Irradiation therapy, chemotherapy or immunosuppressive therapy in the last 5 years
• • 14. Malignancies
• • 15. Severe Parafunction (bruxism and clenching)
• • 16. Poor oral hygiene or active periodontitis
• • 17. Heavy tobacco smoking habit (\> 10 cigarettes per day)