Introduction: This 2-arm parallel trial aimed to assess the number of failures of mandibular fixed retainers bonded with direct and indirect bonding methods at a 5-year follow-up and investigate the stability of intercanine and interpremolar distances.
Methods: Consecutive patients from the clinic of the University of Geneva (Switzerland) were randomly allocated to either direct or indirect bonding of a mandibular fixed retainer at the end of orthodontic treatment. Inclusion criteria included the presence of all mandibular incisors and canines; and the absence of active caries, restorations, fractures, or periodontal disease of these teeth. The patients were randomized in blocks of 4 using an online randomization service, with allocation concealment secured by contacting the sequence generator for assignment. Two and 5 years (T5) after bonding the retainers, the patients were recalled, and impressions were taken. The primary outcome was the 5-year survival of the mandibular fixed retainer bonded with both bonding methods. The secondary outcomes were the intercanine and interpremolar distances and the assessment of unexpected posttreatment changes (ie, changes in torque and/or rotations of the mandibular incisors and canines). Blinding was applicable for outcome assessment only. Kaplan-Meier curves were generated, and a Cox proportional hazard regression model was fitted for bonding type, age, and treatment. Linear mixed models were fitted to intercanine and interpremolar distances: bonding type, time, age, and treatment were modeled as outcomes.
Results: Sixty-four patients were randomized in a 1:1 ratio. At T5, 6 patients without previous failure were lost to follow-up from each group. At T5, the fixed retainer was debonded in 14 patients (54%) for each group. The hazard ratio of indirect bonding to direct bonding was 1.09 (95% confidence interval, 0.26-4.60; P = 0.91); there was no statistically significant difference in survival between the groups. Regarding intercanine and interpremolar distances, none of the tested prognostic factors reached statistical significance. Unexpected posttreatment changes were observed in 6 failure-free patients, all bonded with the direct bonding method. Only 1 patient required debonding of the fixed retainer. No other serious harms were observed.
Conclusions: The 5-year survival rate for both direct and indirect bonding methods was 46%, without a statistically significant difference between bonding methods. Bonded retainers were effective in maintaining intercanine and interpremolar distances. Unexpected posttreatment changes were only observed with retainers bonded with the direct bonding method.
Registration: The trial was not registered.
Protocol: The protocol was not published before trial commencement.
Funding: No funding or conflict of interest to be declared.
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