Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (NCT03150472) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Evaluation of the Ivory Dentin Graft Device
Israel43 participantsStarted 2017-11-07
Plain-language summary
Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen Os) for alveolar ridge preservation following tooth extraction.
The non-inferiority endpoints will be achieved if the competitor treatment group will not be statistically better than the Ivory Graft treatment.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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):
✓. Ability to give informed consent for the study by patient or legal guardian.
✓. Willingness to undergo all follow up visits, as well as unscheduled sick visits.
Exclusion criteria
✕. Pregnancy (all women of child-bearing 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 auto-immune pathologies, in particular elderly
✕0. Serious bone diseases of endocrine aetiology
✕1. Serious disturbances of bone metabolism
✕2. Ongoing treatment with gluco- or mineralocorticoids, or with agents affecting calcium metabolism (e.g. calcitonin, bisphosphonates)
What they're measuring
1
Amount of new bone formation
Timeframe: 4 months after grafting
2
Bone-Graft material integration score to host bone in the alveolar bone core