OBJECTIVES: The aim of this study was to evaluate the efficacy of aloe vera (AV) 
applied in combination with a tongue protector, comparing this with a placebo.
METHODS: A total of 75 patients with burning mouth syndrome (BMS) were divided 
into three groups randomly: Group I (tongue protector three times a day), Group 
II (tongue protector and 0.5 ml AV at 70% three times a day) and Group III 
(tongue protector and 0.5 ml placebo three times a day). Symptoms were evaluated 
by visual analogue scale (VAS), while patient psychological profiles were 
assessed using the Hospital Anxiety-Depression scale and their quality of life 
using the Oral Health Impact Profile 49 (OHIP-49). Treatment continued for 
3 months.
RESULTS: Visual analogue scale pain values improved for all three study groups 
but without statistically significant differences between the groups 
(P = 0.210). Regarding quality of life, no significant differences were found 
between groups with the exception of the OHIP-49 score for handicap. The overall 
clinical improvement was greater for Group II, with a difference almost reaching 
significance.
CONCLUSIONS: The concomitant prescription of tongue protector and AV is 
effective for treating patients with BMS.