Survival of conventionally bonded mandibular retainers with or without enamel sandblasting in orthodontic patients over a 12-month period. A single-centre, split-mouth randomized clinical trial

Abstract

Summary Background The aim of this trial was to assess the effect of enamel sandblasting in addition to the acid-etch technique in reducing first-time failures of fixed mandibular retainers placed over a 12-month period. Materials and methods Ethical approval was obtained. Participants were recruited in a single private practice. The primary outcome of this study was any first-time failure of the mandibular fixed retainer assessed at three timepoints over a 12-month period. Three consecutive teeth either on the left or right side (from lower canine-lower central incisor) were randomly allocated to the intervention (sandblasting) and the control (non-sandblasted). Randomization was performed using a centralized randomization service. The patients were randomized in blocks of four and eight with allocation concealment secured by contacting the sequence generator for group assignment. Blinding of either the patient or clinicians was not possible at time of placement of the mandibular retainer. Results One hundred and ninety-seven participants were randomized to receive enamel sandblasting (intervention) and non-sandblasting (control) in the region of the six anterior mandibular teeth in a split-mouth fashion. Participants were recruited between December 2018 to October 2020. The data for all participants were analysed resulting in 394 observations. Overall, the risk of first-time failure was 11.4%. No difference in first-time failures was observed between the intervention (sandblasting) and control (non-sandblasting) groups [hazard ratio (HR), 1.05; 95% confidence interval (CI), 0.59, 1.88, P = 0.88]. Males had a higher instant probability of first-time failures (HR, 3.18; 95% CI, 1.65–6.14; P < 0.01). Participants with a fair level of co-operation had a lower instant probability of first-time failures (HR, 0.37; 95% CI, 0.16-0.86; P = 0.02). There were no harms reported to either the participant or their dentition. Conclusions No difference in the first-time failures of mandibular bonded retainers placed with conventional etch-bond technique with or without enamel sandblasting was observed. The overall risk of first-time failure was 11.4%. Registration This trial was not registered prior to trial commencement.