Comparative immediate post-treatment outcomes of mandibular mini-implant-supported multiloop edgewise archwire therapy in skeletal Class II malocclusion: a non-randomized bidirectional cohort study

Patient-reported outcomes were assessed with a study-specific questionnaire. The primary comparative analysis used analysis of covariance (ANCOVA), with the post-treatment measurement as the outcome, treatment group as the main predictor, and the corresponding pretreatment measurement as a covariate. Unadjusted change-score comparisons were retained as secondary descriptive analyses.

Multiplicity across the 17 cephalometric outcomes was addressed using Bonferroni and Benjamini-Hochberg false discovery rate (FDR) procedures; questionnaire domains were compared using Mann-Whitney U tests with FDR adjustment. Results: All patients met the predefined clinical finishing criteria of normal overjet and overbite with bilateral Class I canine and molar relationships. Several cephalometric variables were imbalanced at baseline.

In secondary unadjusted change-score analyses, PP-FH, U1-L1, FMIA, IMPA, and ODI remained significant after Bonferroni correction. In the baseline-adjusted ANCOVA, however, only mandibular-incisor variables remained robust after Bonferroni correction: the adjusted experimental-versus-control difference was +29.35 degrees for FMIA (95% CI, 19.37 to 39.33; P < 0.001) and -25.28 degrees for IMPA (95% CI, -35.88 to -14.68; P < 0.001).

U1-L1 remained nominally significant after baseline adjustment (+15.05 degrees; 95% CI, 1.69 to 28.41; P = 0.029) but did not survive multiplicity correction. Adjusted differences in PP-FH, ODI, ANB, and Wits were not statistically significant. After FDR correction of the questionnaire domains, doctor behavior and treatment knowledge remained significantly different between groups.

Conclusions: In this small non-randomized cohort, the strongest baseline-adjusted finding was improved mandibular-incisor control with the mini-implant-supported MEAW protocol, reflected by more favorable FMIA and IMPA outcomes. Unadjusted differences in deep-overbite-related and vertical measurements were substantially attenuated after baseline adjustment, and evidence for superior sagittal skeletal correction was weak.

Because the two protocols differed in both anchorage source and point of force application, the observed differences cannot be attributed to the mini-implant alone. Larger prospectively controlled studies with growth assessment and longer follow-up are required.[A1] [A2] [A1]Please verify the FDR-corrected questionnaire results. The Statistical Analysis section describes FDR correction only for the cephalometric comparisons, and the corrected P values for the questionnaire outcomes are not reported.

In addition, based on the P values currently shown in Table 4, please recheck whether “treatment feeling” remains significant after Benjamini-Hochberg correction. Please report the corrected P values and ensure that the Abstract, Methods, Results, and Table 4 agree. [A2]Thank you for identifying this inconsistency.

We rechecked the questionnaire analyses and applied the Benjamini–Hochberg false discovery rate (FDR) correction across all eight questionnaire domains based on the P values from the two-sided Mann–Whitney U tests. The FDR-adjusted P values were as follows: Daily Life Impact, 0.392; Doctor Behavior, 0.013; Treatment Knowledge, 0.006; Treatment Feeling, 0.057; Reason for Treatment Choice, 0.216; Treatment Motivation, 0.167; Treatment Concern, 0.880; and Level of Care, 0.057.

Accordingly, Treatment Feeling did not remain statistically significant after FDR correction. Only Doctor Behavior and Treatment Knowledge remained statistically significant after correction. We have revised the Statistical Analysis section to explicitly state that the Benjamini–Hochberg procedure was applied across the eight questionnaire domains, and the corrected P values are now reported in Table 4.

The Abstract and Results have also been revised to ensure consistency with Table 4. The separate overall-satisfaction item was analyzed independently and was not included in the FDR correction across the eight questionnaire domains.</p>