Status:
UNKNOWN
Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up
Lead Sponsor:
Ivory Graft Ltd.
Conditions:
Deficiency of Alveolar Ridge (Disorder)
Alveolar Bone Grafting
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
long-term safety and performance of Ivory Dentin Graft. Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen-Os) for alveolar ridge preservation following tooth extr...
Detailed Description
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 effectivenes...
Eligibility Criteria
Inclusion
- Male or female patient 18 up to 80 years.
- Patient requiring at least one implant placement following mandibular pre-molar or molar tooth extraction.
- 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.
- Ability to give informed consent for the study by patient or legal guardian.
- 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
- Pregnancy (all women of childbearing age would be questioned and told by the consenting physician regarding that criteria).
- Known or suspected hypersensitivity to the constituents of the bone graft material (for example porcine collagen)
- Pathologies or conditions contraindicating surgery or presenting with active acute or chronic infections excluding periapical granuloma (for example osteomyelitis, sinusitis), uncontrolled diabetes
- Immunologic disorders or autoimmune pathologies, in particular elderly
- Serious bone diseases of endocrine aetiology
- Serious disturbances of bone metabolism
- Ongoing treatment with gluco- or mineralocorticoids, or with agents affecting calcium metabolism (e.g. calcitonin, bisphosphonates)
- Irradiation therapy, chemotherapy or immunosuppressive therapy in the last 5 years
- Malignancies
- Severe Parafunction (bruxism and clenching)
- Poor oral hygiene or active periodontitis
- Heavy tobacco smoking habit (\> 10 cigarettes per day)
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04868825
Start Date
November 7 2017
End Date
April 1 2025
Last Update
May 3 2021
Active Locations (1)
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1
Assaf HaRofeh Medical Center
Zrifin, Israel, 70300