Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial

Abstract

The objective of this prospective randomized clinical trial was to investigate the relationship between clear aligner (CA) therapy and the development of white spot lesions and compare it with orthodontic fixed appliance (FA) therapy. This was a prospective randomized clinical trial. The setting was the postgraduate orthodontic clinic at Jordan University of Science and Technology. A total of 49 patients (39 female, 10 male; mean age±standard deviation, 21.25±3years) who required orthodontic treatment with either FAs or CAs were randomly allocated into 1 of 2 study groups. Eligibility criteria included healthy patients of both sexes (age range 17-24years), Class I malocclusion with mild-to-moderate crowding (≤5mm), nonextraction treatment plan, and optimum oral hygiene before treatment as determined by clinical examination. The participants were randomly assigned to a study group according to a simple randomization method using a coin toss by the patient; the text or tail side of the coin indicated treatment with CA (group 1), and the head side of the coin indicated orthodontic treatment with FA (group 2). Blinding was applicable for outcome assessment only. CA therapy was performed for group 1 and FA for group 2. Quantitative light-induced fluorescence (QLF) images were taken before treatment (T0) and 3months later (T1). The QLF images were then analyzed to assess the research outcomes. The main outcome was the mean amount of fluorescence loss (ΔF). Number of newly developed lesions, deepest point in the lesion (ΔFMax), lesion area (pixels), and plaque surface area (ΔR30) were measured as secondary outcomes. Descriptive statistics and comparison within and between groups were calculated. In total, 42 of the 49 participants recruited completed the study (19 in the CA group and 23 in the FA group). The mean amount of fluorescence loss was 0.4% for the CA group (P=0.283) and 1.2% for the FA group (P=0.013). The difference between the 2 groups was significant (confidence interval [CI], -1.8 to -0.4; P=0.002). The mean increase in lesion area was 82.2 pixels for the CA group (P <0.001) and 9.3 pixels for the FA group (P=0.225). The difference between the 2 groups was significant (CI, -117 to -75.0; P<0.001). ΔR30 was 1.2% for the CA group and 10.9% for the FA group (CI, 6.847-12.479; P<0.001). The number of newly developed lesions in the CA group was 6 lesions/patient and 8.25 in the FA group (P=0.039). No serious harm on the oral health of the participants in the 2 study groups was observed other than mild gingivitis associated with plaque accumulation. No serious harm was reported by any of the participants. Orthodontic treatment with CAs and FAs caused enamel demineralization. The CA group developed larger but shallower white spot lesions, whereas the FA group developed more new lesions with greater severity, but they were smaller in area. More plaque accumulation was found in the FA group compared with the CA group. NCT04107012. The protocol was published after trial commencement.