Discomfort associated with Invisalign and traditional brackets: A randomized, prospective trial.
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OBJECTIVE: To evaluate differences in discomfort levels between patients treated with aligners and traditional fixed orthodontic appliances. MATERIALS AND METHODS: This blinded, prospective, randomized equivalence two-arm parallel trial allocated 41 adult Class I nonextraction patients to either traditional fixed appliance (6 males and 12 females) or aligner (11 males and 12 females) treatment. Patients completed daily discomfort diaries following their initial treatment appointment, after 1 month and after 2 months. They recorded their levels of discomfort at rest, while chewing, and while biting, as well as their analgesic consumption and sleep disturbances. RESULTS: Both treatment modalities demonstrated similar levels of initial discomfort. There were no significant sex differences. Patients in the traditional fixed appliances group reported significantly (P < .05) greater discomfort than patients in the aligner group during the first week of active treatment. There was significantly more discomfort while chewing than when at rest. Traditional patients also reported significantly more discomfort than aligner patients after the first and second monthly adjustment appointments. Discomfort after the subsequent adjustments was consistently lower than after the initial bonding or aligner delivery appointments. A higher percentage of patients in the fixed-appliance group reported taking analgesics during the first week for dental pain, but only the difference on day 2 was statistically significant. CONCLUSIONS: Patients treated with traditional fixed appliances reported greater discomfort and consumed more analgesics than patients treated with aligners. This trial was not registered.