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Randomized, double-blind, crossover study

Morales-Bozo I et al., (2012) evaluated the efficacy of two mouthrinses in the reduction of xerostomía-associated symptomatology in a randomized, double-blind, cross-over clinical trial with progressive recruitment and a washout period, in 67 adult patients with xerostomia of diverse origin. The median unstimulated salivary flow in the study sample was 0,230 ml/min with a range from 0,04 to 0,982 ml/min.

Rinse 1 was co mposed principally of an aqueous solution containing xylitol, sodium fluoride, cetylpyridinium chloride, sodium chloride and spearmint flavouring. Rinse 2 was composed of the same components as rinse 1, with the addition of propylene glycol, aloe vera, glycerine and citric acid.

On day 1, half of the patients (n = 34, group A) started the study using rinse 1 and the other half (n = 33, group B) startedthe study using rinse 2. Patients used the appropriate solution for 7 days. Later, there was a 4-day washout period, in which the patients were instructed to suspend the use of the rinses. On day 13, the order of the mouthrinses administered to the patients was inverted, and the patients used the rinses for seven more days. At the beginningof days 1 and 13 of the study, a survey determining the xerostomia baseline was performed to evaluate the severity of xerostomia before the use of the rinse being tested.

Both groups of patients were compared with each other with regard to the magnitudes of sensation of dry mouth, sensation of thick saliva, burning tongue, need to drink liquids to swallow and difficulty in swallowing food, both before and after the use of the rinse. In the group of patients displaying one xerostomia-associated pathology (n = 48), rinse 1 relieved only the sensation of dry mouth, in contrast to its effect among patients displaying 2 or more xerostomiaassociated pathologies (n = 19) among which it relieved the need to drink liquids to swallow and the difficulty in swallowing food.

Rinse 2 relieved the need to drink liquids to swallow and the difficulty in swallowing food only among patients displaying 2 or more associated pathologies.

Authors concluded that both rinses were more effective in relieving xerostomıa-associated symptomatology in patients taking 3 or more medicines simultaneously.

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