Effect of mini-implant facilitated micro-osteoperforations on the alignment of mandibular anterior crowding: A randomised controlled clinical trial.

Objective: To assess the effects of mini-implant assisted micro-osteoperforations (MI-MOPs) in the alignment of mandibular anterior teeth, and to explore the intervention's associated pain perception (PP) and root resorption (RR) in adults treated by fixed appliance.

Design: Multicentre, two-arm and single-blinded randomised clinical trial.

Setting: College of Dentistry, University of Baghdad.

Participants: Adolescents (mean age = 18.97 years) undergoing non-extraction orthodontic therapy for the management of mandibular anterior crowding.

Methods: A total of 33 participants (mean age = 18.97 years) undergoing non-extraction orthodontic therapy for the management of moderate mandibular anterior crowding were allocated to the experimental (MI-MOPs, n = 17) or control groups (non-MI-MOPs, n = 16). A series of lower study models were obtained at week 4 (T1), week 8 (T2) and week 12 (T3) in the MI-MOPs group and continued to week 16 (T4) and week 20 (T5) in the non-MI-MOPs group, with all models analysed digitally. Periapical radiographs (PA) were taken before commencing treatment (T0) and T3. Participants were asked to complete a 10-point visual analogue scale (VAS) daily during the first week of treatment.

Results: At T0, the mean Little irregularity index (LII) was 5.1 mm (95% confidence interval [CI] = 4.95-5.23) with no statistically significant difference between groups ( = 0.766). At T1, T2 and T3, t-test showed statistically significant differences in the LII ( < 0.05) in favour of the MI-MOPs group; mean differences (MD) were -1.16mm (95% CI = -1.36 to -0.96), -1.77 mm (95% CI = -1.93 to -1.59) and -1.58 mm (95% CI = -1.67 to -1.48), respectively. Mean treatment time from baseline to final alignment was 10.41 weeks (95% CI = 9.92-10.89) in the MI-MOPs group and 16.62 weeks (95% CI = 16.11-17.13) in the non-MI-MOPs groups, which was statistically significant (MD -6.21 mm, 95% CI = -6.88 to -5.53, < 0.05). Conversely, Mann-Whitney -test and Wilcoxon signed-rank test showed no significant differences in terms of PP and RR between the groups ( > 0.05). The participants in the MI-MOPs group experienced a higher degree of RR ( < 0.05) secondary to intervention. No other significant adverse events were reported during the trial.

Conclusion: This trial found that combining MI-MOPs with non-extraction-based fixed orthodontic therapy in adults mildly shortens the duration of the alignment phase. RR should be monitored throughout the treatment when using MI-MOPs (ClinicalTrials.gov NCT04778241).