D'Aiuto F, Orlandi M, Gunsolley JC Evidence that periodontal treatment improves biomarkers and CVD outcomes. J Periodontol. 2013 Apr;84(4 Suppl):S85-S105. doi: 10.1902/jop.2013.134007. Review.
de Pablo P, Dietrich T, McAlindon TE Association of periodontal disease and tooth loss with rheumatoid arthritis in the US population. J Rheumatol. 2008 Jan;35(1):70-6. Epub 2007 Nov 15.
Mak A, Kow NY, Schwarz H, Gong L, Tay SH, Ling LH Endothelial dysfunction in systemic lupus erythematosus - a case-control study and an updated meta-analysis and meta-regression. Sci Rep. 2017 Aug 4;7(1):7320. doi: 10.1038/s41598-017-07574-1.
Orlandi M, Suvan J, Petrie A, Donos N, Masi S, Hingorani A, Deanfield J, D'Aiuto F Association between periodontal disease and its treatment, flow-mediated dilatation and carotid intima-media thickness: a systematic review and meta-analysis. Atherosclerosis. 2014 Sep;236(1):39-46. doi: 10.1016/j.atherosclerosis.2014.06.002. Epub 2014 Jun 17. Review.
Rutter-Locher Z, Smith TO, Giles I, Sofat N Association between Systemic Lupus Erythematosus and Periodontitis: A Systematic Review and Meta-analysis. Front Immunol. 2017 Oct 17;8:1295. doi: 10.3389/fimmu.2017.01295. eCollection 2017.
Salmon JE, Roman MJ Accelerated atherosclerosis in systemic lupus erythematosus: implications for patient management. Curr Opin Rheumatol. 2001 Sep;13(5):341-4. Review.
Skamra C, Ramsey-Goldman R Management of cardiovascular complications in systemic lupus erythematosus. Int J Clin Rheumtol. 2010 Feb 1;5(1):75-100.
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.