Alveolar Bone Grafting — Safety and Efficacy Evaluation of the Ivory Dentin Graft Device
Citation(s)
Abraham CM A brief historical perspective on dental implants, their surface coatings and treatments. Open Dent J. 2014 May 16;8:50-5. doi: 10.2174/1874210601408010050. eCollection 2014.
Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;(5):CD010176. doi: 10.1002/14651858.CD010176.pub2. Review.
Binderman I, Hallel G, Nardy C, Yaffe A, Sapoznikov L A novel procedure to process extracted teeth for immediate grafting of autogenous dentin. J Interdiscipl Med Dent Sci, 2014; 2(6). http://dx.doi.org/10.4172/jimds.1000154
Campbell KM, Casas MJ, Kenny DJ Ankylosis of traumatized permanent incisors: pathogenesis and current approaches to diagnosis and management. J Can Dent Assoc. 2005 Nov;71(10):763-8.
Patel K, Mardas N, Donos N Radiographic and clinical outcomes of implants placed in ridge preserved sites: a 12-month post-loading follow-up. Clin Oral Implants Res. 2013 Jun;24(6):599-605. doi: 10.1111/j.1600-0501.2012.02500.x. Epub 2012 Jun 3.
Safety and Efficacy Evaluation of the Ivory Dentin Graft Device
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
