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 range
18 Years – 80 Years
Sex
ALL
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 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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)
3. Irradiation therapy, chemotherapy or immunosuppressive therapy in the last 5 years