Randomised controlled trial.Fifty patients (46 females, four males) aged 61.18 ± 12.27 years with a clinical history of continuous symptoms of oral burning or pain for more than six months, no clinical abnormalities that could account for the symptoms and normal blood test findings were allocated using computer randomisation to either the control group who were given information only, or to the experimental group that received the same information plus the tongue protector. The protector consisted of a transparent, low density polyethylene sheath covering the tongue from the tip to the posterior third. The trial length was two months.The primary outcome was oral symptoms as recorded using a visual analog scale (VAS) consisting of a 10cm vertical line marked from 0 (=no pain) to 10 (= most severe pain experienced). Secondary outcome was quality of life, measured using OHIP-49 and SF-36.Change in VAS was reported as mean (± s.d.). For the non-intervention group this was 1.4 (± 1.6). For the intervention group it was 3.6 (± 2.2). This difference was statistically significant (P<0.001). For the OHIP-49 the mean changes were 1.92 (± 4.93) and 18.44 (± 29.53) respectively, which was statistically significant (P=0.008). Three of the eight measures in the SF-36 showed a statistically significant improvement in the tongue protector group. Confidence intervals were not reported for any of the measures.Although a statistical significance was observed in the VAS, studies are needed to reproduce these findings in larger series, over longer periods of time and involving an adequate sample of patients.
展开▼
