Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up

Launched by IVORY GRAFT LTD. · Apr 27, 2021

Keywords

ClinConnect Summary

This clinical investigation is part of the post-market development process of the investigational device of Ivory Graft Ltd. in order to satisfactory validate the safety, tolerability and effectiveness of Ivory Dentin Graft as required by the sponsor's European Union (EU) notified body.

The clinical Investigation was conducted with the stated confirmation applying European regulations; International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines, ISO 14155:2011, and with a relevant subject population for the study objectives. Israeli Ministry of Health registrati...

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 7 follow up visits: 1 week, 1, 4, 6 and 10 months, 2.5 years and 5 years following dental graft implantation, as well as unscheduled sick visits.
• Exclusion Criteria:
• • 6. Pregnancy (all women of childbearing 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 autoimmune 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)