Management of xerostomia in older patients : a randomised controlled trial evaluating the efficacy of a new oral lubricant solution. Efficacy of a new oral lubricant solution in the management of psychotropic drug-induced xerostomia: a randomized controlled trial. Safety and effectiveness of topical dry mouth products containing olive oil, betaine, and xylitol in reducing xerostomia for polypharmacy-induced dry mouth. Subjective and clinical evaluation of oral lubricants in xerostomic patients. Clinical trial of a mucin-containing oral spray for treatment of xerostomia in hospice patients. Salivary stimulation by chewing gum and lozenges in rheumatic patients with xerostomia. Chewing gum and a saliva substitute alleviate thirst and xerostomia in patients on haemodialysis. Comparison between saliva stimulants and a saliva substitute in patients with xerostomia and hyposalivation. Treatment of xerostomia with polymer-based saliva substitutes in patients with Sjögren's syndrome.
Xerostomia is a subjective sensation of mouth dryness that may frequently occur in older patients.
                To compare the clinical efficacy and acceptability of a new oxygenated glycerol triester (OGT) oral spray taken five times daily with that of a commercially available saliva substitute Saliveze in the treatment of xerostomia.
                Forty-one institutionalised patients (28 women, 13 men; mean age 84 +/- 7 years) were randomly assigned to receive either OGT or Saliveze in a 2-week, randomised, parallel-group study. Clinical assessment of xerostomia included evaluation of mouth dryness using a self-rated, 10cm long visual analogue scale (VAS), objective assessment of oral tissue condition using a four-point ordinal scale and subjective assessment of symptoms of xerostomia using dichotomous responses to a questionnaire. The primary endpoint was the day (D) 14 patient-based mouth dryness score measured on a self-rated VAS.
                At D14, OGT resulted in significantly greater efficacy with respect to mouth dryness (mean between-treatment difference 2.1 +/- 0.1, 95% CI 1.9, 2.3; p = 0.001), swallowing difficulty (1.8 +/- 0.3, 95% CI 1.5, 2.1; p = 0.001), speech difficulty (1.1 +/- 0.2, 95% CI 1.0, 2.4; p = 0.04) and overall sensation of symptom relief (2.7 +/- 1.2, 95% CI 1.9, 3.8; p = 0.001). Objective assessment of oral tissues also showed significantly better improvement with OGT spray with respect to dryness (p = 0.01), stickiness (p = 0.005) and dullness (p = 0.001) of oral mucosa; severity of mucositis (p = 0.01); and thickening of the tongue (p = 0.03). A significant difference in taste acceptability was also noted in favour of OGT (1.4 +/- 0.6, 95% CI 1.2, 1.9; p = 0.04).
                OGT lubricant oral spray was superior to Saliveze in improving xerostomia and oral tissue condition in older institutionalised patients. Xerostomia is a subjective sensation of mouth dryness often occurring as an unwanted effect of psychotropic drugs.
                The clinical efficacy and acceptability of a new oxygenated glycerol triester (OGT) oral spray (1 or 2 sprays up to 4 times daily) in the treatment of xerostomia was compared with those of a commercially available artificial saliva substitute (ASS [Saliveze]) in a 2-week, open-labeled, randomized, parallel-group study. Clinical assessment of xerostomia included evaluation of mouth dryness by means of a 10-cm-long visual analog scale, objective blinded assessment of the oral tissue condition by a dental hygienist by means of a 4-point ordinal scale, and subjective patient-based assessment of dry mouth symptoms by means of dichotomous responses to a questionnaire. [Day 14 - baseline] patient-based mouth dryness score was the primary end point.
                Seventy-four patients (41 women and 33 men, 44 +/- 15 years) undergoing long-term psychotropic drug treatment were consecutively enrolled. At day 14, OGT resulted in better efficacy than ASS in mouth dryness score (mean difference, 1.2 +/- 0.4; P = 0.006), speech difficulties (mean difference, 1.2 +/- 0.4; P = 0.005), taste (mean difference, 1.1 +/- 0.4; P = 0.02), and overall mouth condition (mean difference, 1.4 +/- 0.9; P = 0.005). Taste of OGT was better than that of ASS (mean difference, 1.4 +/- 0.6; P = 0.04), as was OGT acceptability (mean difference, 1.4 +/- 0.9; P = 0.005).
                Oxygenated glycerol triester lubricant oral spray was superior to a commercially available ASS in improving xerostomia and overall condition of the oral tissue. Polypharmacy is a common cause of salivary hypofunction, producing symptoms of dry mouth or xerostomia, especially among older populations. As the number of older people continues to increase, polypharmacy-induced salivary hypofunction is becoming an increasing problem. Many over-the-counter products are available for relieving symptoms of dry mouth, but few have been tested in controlled clinical investigations. The purpose of this investigation was to evaluate the safety and efficacy of a group of topical dry mouth products (toothpaste, mouth rinse, mouth spray and gel) containing olive oil, betaine and xylitol. Forty adults were entered into this single-blinded, open-label, cross-over clinical study and 39 completed all the visits. Subjects were randomly assigned at baseline to using the novel topical dry mouth products daily for 1 week, or to maintain their normal dry mouth routine care. After 1 week, they were crossed over to the other dry mouth regimen. The results demonstrated that the use of the novel topical dry mouth products increased significantly unstimulated whole salivary flow rates, reduced complaints of xerostomia and improved xerostomia-associated quality of life. No clinically significant adverse events were observed. These data suggest that the daily use of topical dry mouth products containing olive oil, betaine and xylitol is safe and effective in relieving symptoms of dry mouth in a population with polypharmacy-induced xerostomia. The purpose of this investigation was to evaluate and compare four oral lubricants in relation to oral mucosal status, perceived relief of dry mouth symptoms, and patient acceptance. Three commercial oral lubricants--two sprays and one gel--and a home remedy of margarine were evaluated. Twenty-five xerostomic/salivary gland dysfunctional patients demonstrating < 0.20 mL/min of unstimulated whole saliva participated in the randomized, four-phase, cross-over study. Each phase included a ten-day use of oral lubricants, followed by a four-day washout period. On the first and tenth days of use, lip and buccal mucosa dryness and perceived oral dryness were evaluated. Patient acceptance of the oral lubricant was evaluated at the end of each ten-day period. The Wilcoxon matched-pairs signed-rank test was used to analyze data over time and between-group differences. The gel group reported a statistically significant improvement in perceived oral dryness from Day 1 to Day 10. No other significant within-group differences were found. Subjects rated the gel significantly better than margarine for convenience, perceived value, minutes of relief, and in the "overall" rating. No other significant between-group differences were noted. Thirty-five hospice patients complaining of dry mouth entered a double-blind, single-phase placebo-controlled trial of a mucin-containing oral spray (Saliva Orthana) for the relief of xerostomia. The sprays were administered ad libitum for two weeks by the patients themselves, with nursing help as necessary. A detailed history and examination were undertaken, together with collection of microbiological specimens, at entry and after seven and 14 days of spray usage, respectively. Thirty-one patients were available for follow-up at seven days and 26 patients after 14 days. Relief of oral dryness during the day was reported by 9/15 patients on Saliva Orthana and 10/16 patients on placebo by day 7, with a similar degree of improvement maintained to day 14. The corresponding figures by day 7 for relief of dryness at night were 8/15 for Saliva Orthana and 8/16 for placebo. There were no statistically significant differences between those on active and those on placebo spray for any of the oral symptoms recorded. Neither spray had any major impact on the oral microflora. However, the majority of patients in both treatment groups wished to continue using a mouth spray at the end of their involvement in the trial. Whilst the data from this study provide no evidence for increased benefit of a mucin-containing spray over a mucin-free placebo among xerostomic hospice patients, it is clear that both sprays provided worthwhile symptomatic relief of oral dryness for many of the participants. The effect of chewing gum and lozenges in relieving the signs and symptoms of xerostomia was studied in a 2-wk cross-over clinical trial in 18 rheumatic patients with dry mouth symptoms and low salivary flow rates. Resting flow was measured before (PRESTIM) a chewing stimulated flow rate test (STIM), and also 5 min after (POSTSTIM). STIM flow (mean 1.0 ml/min) was not affected by the test regimens. In the lozenge regimen, mean PRESTIM flow in the group increased from 0.11 to 0.14 ml/min and POSTSTIM from 0.10 to 0.13. In the chewing gum regimen, PRESTIM flow (mean 0.13 ml/min) did not change, whereas POSTSTIM flow increased from 0.13 to 0.16 ml/min. In terms of patients' preferences, chewing gum and lozenges were ranked equal. Both these physiologic stimuli had few side-effects. Subjective symptoms were relieved in about one-third of the subjects, but relief was not always verified by improved flow rates. The regimens were not found to influence buffering capacity; salivary counts of mutans streptococci, lactobacilli, and candida; or oral sugar clearance time. Most patients on haemodialysis (HD) have to maintain a fluid-restricted diet to prevent a high interdialytic weight gain (IWG). The prevalence of xerostomia (the feeling of a dry mouth) is higher in HD patients than in controls. Recently, we demonstrated that xerostomia and thirst were positively correlated with IWG in HD patients. Thus, this may play a role as a stimulus for fluid intake between dialysis sessions. The aim of the present study was to investigate the effect of chewing gum or a saliva substitute on xerostomia, thirst and IWG.
                This study was a randomized two-treatment crossover design with repeated measures. After the use of chewing gum or saliva substitute for 2 weeks, a wash-out period of 2 weeks was introduced and hereafter the other regimen was carried out. Xerostomia and thirst were assessed by validated questionnaires as xerostomia inventory (XI) and dialysis thirst inventory (DTI), at baseline and after each treatment period, as were IWG and salivary flow rates.
                Sixty-five HD patients (42 men, 54.6+/-14.1 years; 23 women, 54.7+/-16.3 years) participated in this study. Chewing gum decreased XI from 29.9+/-9.5 to 28.1+/-9.1 (P<0.05). Chewing gum as well as a saliva substitute reduced DTI significantly (P<0.05), but no differences occurred for the average IWG or salivary flow rates.
                The use of chewing gum and, to a lesser extent, a saliva substitute may alleviate thirst and xerostomia in some HD patients. The purpose of this study was to assess patient preference and product efficacy of three non-prescription products for the symptomatic relief of xerostomia. The study group consisted of 80 individuals with a complaint of chronic (> six months) xerostomia and an unstimulated salivary flow rate of < 0.1 mL/min. The three products--a sorbitol/xylitol-sweetened chewing gum, a sorbitol-sweetened sour lemon lozenge, and a sorbitol/xylitol-sweetened artificial saliva substitute spray--were assigned in a permuted block randomization scheme. Each product was used for two weeks with an interval of one week between trials. The study did not identify any product to be statistically significant in terms of patient preference. Kruskal-Wallis testing revealed no statistical significance (P > 0.589) among the products. No product demonstrated marked efficacy in stimulating salivary output. ANOVA analysis followed by Tukey HSD testing revealed no significant difference between the baseline paraffin-stimulated mean flow rate and the gum- and lozenge-stimulated flow rates. To determine the efficacy of 3 types of polymer-based saliva substitutes in reducing oral dryness in patients with Sjögren's syndrome (SS).
                Subjective efficacy of 3 different saliva substitutes (determined by self-administered questionnaire) was evaluated in a double-blind, placebo-controlled trial in 43 patients with primary and secondary SS. High-viscosity versus low-viscosity xanthan gum-based saliva substitutes were also compared in 33 SS patients. Salivary flow rates (SFR) were determined to examine correlations between the SFR and the subjective efficacy of the saliva substitute.
                Neither the saliva substitutes nor the placebo was truly effective. Preference for a particular saliva substitute over placebo was equally distributed among the 3 types of substitutes. The SFR of patients who preferred polyacrylic acid-based saliva substitutes was lower than that in patients who preferred the porcine mucin-based substitute (P < 0.05). Patients whose oral dryness was reduced by low-viscoelastic substitutes had a low stimulated SFR ( < 0.20 ml/minute; P < 0.05).
                The optimal properties of a saliva substitute are not the same for all patients with SS, but are dependent on such parameters as the individual SFR. Thus, to determine the best saliva substitute for a particular patient, it is necessary to have the patient try a number of substitutes of different viscoelastic properties.
There is no strong evidence from this review that any topical therapy is effective for relieving the symptom of dry mouth. OGT spray is more effective than an aqueous electrolyte spray (SMD 0.77, 95% CI 0.38 to 1.15) which is approximately equivalent to a mean difference of 2 points on a 10-point VAS scale for mouth dryness. Chewing gums appear to increase saliva production in those with residual secretory capacity and may be preferred by patients, but there is no evidence that gum is better or worse than saliva substitutes. Integrated mouthcare systems and oral reservoir devices may be helpful but further research is required to confirm this. Well designed, adequately powered randomised controlled trials of topical interventions for dry mouth, which are designed and reported according to CONSORT guidelines, are required to provide evidence to guide clinical care. For many people the symptom of dry mouth is a chronic problem and trials should evaluate whether treatments are palatable, effective in reducing xerostomia, as well as the long-term effects of treatments on quality of life of those with chronic dry mouth symptoms.