Bonded versus vacuum-formed retainers: a randomized controlled trial. Part 1: stability, retainer survival, and patient satisfaction outcomes after 12 months.

BACKGROUND: There is a shortage of evidence on the best type of retainer. OBJECTIVES: Evaluate upper and lower bonded retainers (BRs) versus upper and lower vacuum-formed retainers (VFRs) over 12 months, in terms of stability, retainer survival, and patient satisfaction. TRIAL DESIGN: Two-arm parallel group multi-centre randomized controlled clinical trial. METHODS: Sixty consecutive patients completing fixed appliance therapy and requiring retainers were recruited from 3 hospital departments. They were randomly allocated to either upper and lower labial segment BRs (n = 30) or upper and lower full-arch VFRs (n = 30). Primary outcome was stability. Secondary outcomes were retainer survival and patient satisfaction. A random sequence of treatment allocation was computer-generated and implemented by sealing in sequentially numbered opaque sealed envelopes independently prepared in advance. Patients, operators and outcome could not be blinded due to the nature of the intervention. RESULTS: Thirty patients received BRs (median [Mdn] age 16 years, inter-quartile range [IQR] = 2) and 30 received VFRs (Mdn age 17 years, IQR = 4). Baseline characteristics were similar between groups. At 12 months, there were no statistically significant inter-group differences in post-treatment change of maxillary labial segment alignment (BR = 1.1 mm, IQR = 1.56, VFR = 0.76 mm, IQR = 1.55, P = 0.61); however, there was greater post-treatment change in the mandibular VFR group (BR = 0.77 mm, IQR = 1.46, VFR = 1.69mm, IQR = 2.00, P = 0.008). The difference in maxillary retainer survival rates were statistically non-significant, P = 0.34 (BR = 63.6%, 239.3 days, 95% confidence interval [CI] = 191.1-287.5, VFR = 73.3%, 311.1 days, 95% CI = 278.3-344.29). The mandibular BR had a lower survival rate (P = 0.01) at 12 months (BR = 50%, 239.3 days 95% CI = 191.1-287.5, VFR = 80%, 324.9 days 95% CI = 295.4-354.4). More subjects with VFRs reported discomfort (P = 0.002) and speech difficulties (P = 0.004) but found them easier to clean than those with BRs (P = 0.001). LIMITATIONS: Results are after 1 year and we do not know how much the removable retainers were worn. CONCLUSIONS: After 1 year, there is no evidence of a significant difference in stability or retainer survival in the maxilla. In the mandible, BRs are more effective at maintaining mandibular labial segment alignment, but have a higher failure rate. In comparison with patients wearing VFRs, patients wearing BRs reported that they caused less interference with speech, required less compliance to wear them, and were more comfortable to wear than VFRs. Patients found the BRs harder to keep clean. TRIAL REGISTRATION: The trail was not registered.