Traumatic oral ulceration (TOU) is one of the most common side effects of orthodontic treatments. The objective of this trial is to compare the clinical efficacy of an 80% Aloe Vera gel, prepared using a master formula, versus a commercial 0.12% Chlorhexidine (CHX) gel for TOU prevention in participants wearing fixed orthodontic appliances. This report represents a single-centre, university-based, double-blinded, randomized controlled trial with 2 parallel arms. Patients aged 12 years or older, in the permanent dentition, and about to start fixed orthodontic treatment in this university setting were randomly allocated to use either Aloe Vera or CHX gel, following the cementation procedure. Pre-treatment and 1 month after the cementation clinical assessment and digital photographic images were taken of the teeth and assessed by 2 clinical assessors for the presence or absence of TOUs. A total of 140 were randomized and completed the trial. The overall prevalence of TOUs was 43.6%. Overall 5.7% of patients treated with Aloe Vera gel showed did not suffer from TOUs, whereas in the CHX arm, a total of 57 (81.4%) were affected by this outcome reaching a significant result (p < 0.001). In terms of relative risk (RRs) and confidence intervals (CIs), Aloe Vera provided better results than CHX with an RR of 0.07 (95%CI 0.03-0.16; p < 0.001), and with a patients' number needed to treat of 1.3 (95%CI 1.16-1.54). There were no adverse effects. These results suggest that Aloe Vera gel administration in patients with fixed orthodontic appliances could be important for effective prevention of TOU.
Keywords: Bracket cementation; Double-blind randomized clinical trial; Periodontal Index; Traumatic ulcers; Wound healing.