Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up (NCT04868825) | Clinical Trial Compass
UnknownNot Applicable
Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up
Israel41 participantsStarted 2017-11-07
Plain-language 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 extraction.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
✕. 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
✕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
Success of implant placement in a rigid post grafting site
Timeframe: 5 years after grafting
2
Number of Participants with Treatment-Related Adverse Events