Effects of Xerostom^® products on xerostomia in primary Sjögren’s syndrome: A randomized clinical trial

Abstract

Objectives To assess the effects of Xerostom® toothpaste and mouthwash in primary Sjögren's syndrome (pSS) patients with xerostomia. Subjects and Methods A double‐blinded, randomized study where patients were assigned at baseline test or control products. Patients used the products 3 times/day/28 days. We used a visual analogue scale (VAS) for xerostomia and an Oral Health Impact Profile‐14 (OHIP‐14), baseline and after treatment, to assess possible improvement. Results A total of 28 patients with pSS were included in this study, but only 24 finished it (all women, mean age 55.21 ± 11.87), and 13 patients received the test and 11 the control. VAS and OHIP‐14 scores decreased in both groups after treatment but significant differences between groups were not found. We do not detect VAS intragroup significant differences before and after treatment in test and control groups. A significant improvement in OHIP‐14 was identified in the treatment group, while no significant differences were observed in the control group. No adverse effects were present. Conclusions Xerostom® toothpaste and mouthrinse may alleviate and improve quality of life without associated side effects, but further research with a larger number of participants and follow‐up are necessary to establish the positive efficacy of these topical products in pSS patients.

Treatment alternatives for dry mouth: A scoping review

“…Finally, another randomized controlled trial that assessed the combined application of Xerostom mouthwash and Xerostom toothpaste in primary Sjögren’s syndrome patients, reported a significant improvement in OHRQoL before and after treatment, which was not observed in the control group. No differences in the intragroup VAS scale before and after treatment were observed ( 20 ) ( Table 2 , 2 cont.).…”

“…Five studies evaluated agents that failed to improve oral dryness, which included: chewing gum ( 26 ), 4% pilocarpine drops ( 25 ), Xerostom® tooth paste and mouthwash (although they did improve OHRQoL) ( 20 ), ALTENS ( 31 ) and LLLT ( 32 ). Although these reports suggest a lack of efficacy of these treatments, care must be taken when interpreting these results.…”

“…For example, although the study of Duruk and Eser ( 26 ) failed to show any effect of chewing gum for the improvement of dry mouth, the effect of chewing gum was tested specifically on patients complaining of dry mouth during hemodialysis, thus is not necessarily extrapolable to other conditions. Also, some of these studies had a reduced sample size ( 20 , 25 ) and high number of dropouts ( 25 , 31 ), thus the lack of significant results could be related to those issues.…”

A Clinical Study on the Efficacy and Tolerability of a New Topical Gel and Toothpaste in Patients with Xerostomia: A Randomized Controlled Trial

“…The efficacy of the product has been demonstrated in a controlled clinical trial involving 40 polymedicated patients with dry mouth. A recent study published by López-Pintor [ 35 ] has used this same product in a small group of patients with Sjögren’s syndrome, with observable improvement of the symptoms. Well-designed, randomized and controlled trials of sufficient statistical power are needed to analyze topical treatments for dry mouth following the Consort Statement and provide guidelines for clinical management.…”

Oral Mucosa in Cancer Patients—Putting the Pieces Together: A Narrative Review and New Perspectives

“…However, there is concern about products based on acidic formulations regarding their erosive potential in already susceptible patients. In this respect, a non-acidic composition has been included in numerous guidelines and systematic reviews for the proven benefits in dry mouth patients [ 73 , 74 , 75 , 76 , 77 , 78 , 79 ].…”