Association Between Early Pain and Miniscrew-Related Oral Impact After Orthodontic Miniscrew Placement: A Prospective...

Background/Objectives: Evidence integrating patient-reported outcomes with the clinical performance of orthodontic miniscrews remains limited. This study evaluated pain, miniscrew-related oral impact, and six-month clinical outcomes following miniscrew placement. Methods: In this single-centre prospective observational cohort, 111 patients were screened, 104 were enrolled, and 100 patients receiving 270 clinically indicated miniscrews contributed complete data. Pain was assessed using a visual analogue scale immediately after placement, at 24 h, and at one week. A preliminary eight-item miniscrew-related oral-impact questionnaire was completed at one week. Analyses included the Friedman test with Holm-adjusted pairwise comparisons, Spearman correlations, and logistic generalised estimating equations (GEEs) accounting for within-patient clustering. Results: Median pain decreased from 6.0 (IQR, 3-8) immediately after placement to 4.0 (IQR, 0-7.25) at 24 h and 0.0 (IQR, 0-2) at one week (p < 0.001; Kendall's W = 0.568; pairwise r = 0.366-0.758). Analgesics were used by 57% of participants. The mean oral-impact score was 6.08 ± 5.92 on a 0-32 scale. Greater immediate post-placement pain was associated with higher oral-impact scores (ρ = 0.431; p < 0.001). At six months, 250 of 270 miniscrews were successful (92.6%). At the miniscrew level, soft-tissue injury and localised inflammation affected 7.8% and 4.4%, respectively. No examined factor was reliably associated with failure in the clustered GEE model. At the patient level, 78% were satisfied or very satisfied, and 92% would recommend the procedure. Conclusions: Pain decreased substantially within one week, while greater early pain was associated with less favourable oral-impact scores. A 92.6% six-month success rate and favourable patient acceptance were observed. The questionnaire requires further validation, and the exploratory failure estimates require confirmation.