To assess the impact of treatment with orthodontic aligners (OA) on oral health-related quality of life (OHRQoL) in patients with trisomy 21 (T21) compared to non-syndromic patients. The sample consisted of 30 patients, both sexes, aged between 11 and 35 years, divided into two groups: T21 (n=10, patients with T21, treated prospectively) and CONTROL (n=20, control group, non-syndromic patients, from the Orthodontic Laboratory of UNOPAR). In both groups, patients were treated with Invisalign orthodontic aligners (Align Technology), following the same treatment parameters. Participants, assisted by their caregivers, when necessary, answered Oral Health Impact Profile (OHIP-14) instrument and the patient's guardians answered the Oral Health Scale for People with Down's syndrome (OHDS) instrument, before (T0) and after 30 (T1), 180 (T2), and 365 (T3) days from the start of treatment. Friedman tests with Bonferroni correction and Mann-Whitney tests were used (p<.05). For the OHDS instrument, it was observed that for the eating and communication domains and an overall score, the treatment with OA positively impacted the lives of T21 patients (p<.05). Regarding the OHIP-14 instrument, the intragroup evaluation showed that in the CONTROL group, there was no significant difference between the evaluated times; while for the T21 group, there was a significant positive impact (p<.05). The results showed that the treatment with aligners positively impacted the OHRQoL of T21 patients, and these results were perceived by caregivers, mainly in relation to issues related to eating and communication.
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