Harms and adverse events in clinical research

Harm is "the totality of possible adverse consequences of an intervention or therapy."1 An adverse event is any unfavorable or harmful occurrence in a patient, temporarily related to a medical intervention, but without any judgment about causality.1 Although many biological and mechanical risk factors have been associated with external apical root resorption (EARR), a causal relationship has not yet been established.2 Thus, EARR is an adverse event occurring in orthodontic patients, and its research is a harm-related issue.

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