Periapical periodontitis or apical periodontitis (AP) is an acute or chronic inflammatory lesion around the apex of a tooth root, most commonly caused by bacterial invasion of the pulp of the tooth. It is a likely outcome of untreated dental caries (tooth decay), and in such cases it can be considered a sequela in the natural history of tooth decay, irreversible pulpitis and pulpal necrosis. Other causes can include occlusal trauma due to high spots after restoration work, extrusion from the tooth of root filling material, or bacterial invasion and infection from the gums. Periapical periodontitis may develop into a periapical abscess, where a collection of pus forms at the end of the root, the consequence of spread of infection from the tooth pulp (odontogenic infection), or into a periapical cyst, where an epithelial lined, fluid-filled structure forms. Etymologically, the name refers to inflammation (Latin, -itis) around (peri- ) the root tip or apex (-apical) of the tooth (-odont-). Periradicular periodontitis is an alternative term. Diagnosis
The radiographic features of periapical inflammatory lesions vary depending on the time course of the lesion. Because very early lesions
may not show any radiographic changes, diagnosis of these lesions relies solely on the clinical symptoms. More chronic lesions may show lytic (radiolucent) or sclerotic (radiopaque) changes, or both. Classification
Classification of periapical periodontitis is usually based on whether the process is acute/symptomatic or chronic/asymptomatic. (Note: alternative names for periapical periodontitis include apical periodontitis and periradicular periodontitis.) Acute periapical periodontitis
Acute (or symptomatic) periapical periodontitis....
Sarepta and patient groups wanted to use the standard of historical controls, personal testimonies, and the presence of altered dystrophin in the body. On April 25, 2016, the Advisory Committee Panel voted against approval;. However, in June 2016, FDA requested for additional data from Sarepta to confirm findings of dystrophin production by eteplirsen. Janet Woodcock, director of the FDAs Center for Drug Evaluation and Research, overruled the panel, and FDA Commissioner Robert Califf deferred to her decision. Eterplirsen received accelerated approval on September 19, 2016.The European Medicines Agency reviewed the molecule in 2018, and refused to approve it.Following the approval of eteplirsen, two other drugs of a similar kind, golodirsen and viltolarsen received provisional approval from the FDA for the treatment of people with a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping as well as casimersen for exon 45 skipping. Society and culture
Economics
The US list price of eteplirsen is US$300,000 per year of treatment. The Institute for Clinical and Economic Review has found the drug not cost effective at the list price when the cost of one Quality-adjusted life year (QALY) was equal to US$150,000. References
External links
"Eteplirsen". Drug Information Portal. U.S. National Library of Medicine.