Medical Device Complication — Monitoring System for the Wearing of Orthodontic Elastics
Citation(s)
Al-Moghrabi D, Salazar FC, Pandis N, Fleming PS Compliance with removable orthodontic appliances and adjuncts: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2017 Jul;152(1):17-32. doi: 10.1016/j.ajodo.2017.03.019.
Mizrahi E Risk management in clinical practice. Part 7. Dento-legal aspects of orthodontic practice. Br Dent J. 2010 Oct 23;209(8):381-90. doi: 10.1038/sj.bdj.2010.926.
Schott TC, Goz G Applicative characteristics of new microelectronic sensors Smart Retainer(R) and TheraMon(R) for measuring wear time. J Orofac Orthop. 2010 Sep;71(5):339-47. doi: 10.1007/s00056-010-1019-3. Epub 2010 Oct 21. English, German.
OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen
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.
