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One of the risks of this approach is that the targeted periodontal pathogens are resistant or poorly susceptible to the antibiotic drug selected, affecting the efficacy of the antimicrobial therapy, and increasing the risk of treatment failure. Although many clinical trials have shown that adjunctive systemic antibiotics combined with mechanical subgingival cleaning of the teeth offer additional clinical improvements compared to cleaning alone especially in severe disease these results are difficult to translate to everyday practice because not all patients show the same degree of long-term clinical benefit

32 However, at no point in this voluminous material is the FDA explicit about how it will process the required information or make its APPH determination