A comparison of artificial saliva and chewing gum in the management of xerostomia in patients with advanced cancer. Efficacy of pilocarpine lozenge for post-radiation xerostomia in patients with head and neck cancer. Comparison between saliva stimulants and saliva substitutes in patients with symptoms related to dry mouth. A multi-centre study. A double-blind, crossover study of Biotène Oralbalance and BioXtra systems as salivary substitutes in patients with post-radiotherapy xerostomia. Salivary stimulation by chewing gum and lozenges in rheumatic patients with xerostomia. Controlled study of lactoperoxidase gel on oral flora and saliva in irradiated patients with oral cancer. Effects of mouthrinses with linseed extract Salinum without/with chlorhexidine on oral conditions in patients with Sjögren's syndrome. A double-blind crossover investigation. The cholinesterase inhibitor physostigmine for the local treatment of dry mouth: a randomized study. Improvement of oral mucosa with mucin containing artificial saliva in geriatric patients. Comparing Moi-Stir to lemon-glycerin swabs. Comparison between saliva stimulants and a saliva substitute in patients with xerostomia and hyposalivation. Comparison between new saliva stimulants in patients with dry mouth: a placebo-controlled double-blind crossover study. Patient preferences in a preliminary study comparing an intra-oral lubricating device with the usual dry mouth lubricating methods. Chewing gum and a saliva substitute alleviate thirst and xerostomia in patients on haemodialysis. Treatment of xerostomia: a double-blind trial in 108 patients with Sjögren's syndrome. Effect of Saliment on parotid salivary gland secretion and on xerostomia caused by Sjögren's syndrome. Buffering effect of a prophylactic gel on dental plaque in institutionalised elderly. The effect of a chewing gum on salivary secretion, oral mucosal friction, and the feeling of dry mouth in xerostomic patients. Effects of a betaine-containing toothpaste on subjective symptoms of dry mouth: a randomized clinical trial. Treatment of xerostomia with polymer-based saliva substitutes in patients with Sjögren's syndrome. Subjective assessment of a new moisturizing mouth spray for the symptomatic relief of dry mouth. Efficacy of a novel lubricating system in the management of radiotherapy-related xerostomia. Mucin-containing lozenges in the treatment of intraoral problems associated with Sjögren's syndrome. A double-blind crossover study in 42 patients. Efficacy of a new oral lubricant solution in the management of psychotropic drug-induced xerostomia: a randomized controlled trial. Management of xerostomia in older patients : a randomised controlled trial evaluating the efficacy of a new oral lubricant solution. A double-blind crossover trial of Oral Balance gel and Biotene toothpaste versus placebo in patients with xerostomia following radiation therapy. Different saliva substitutes for treatment of xerostomia following radiotherapy. A prospective crossover study. Clinical trial of a mucin-containing oral spray for treatment of xerostomia in hospice patients. A double-blind cross-over trial of a mucin-containing artificial saliva. Use of a mucoadhesive disk for relief of dry mouth: a randomized, double-masked, controlled crossover study. Comparison of the effect of the linseed extract Salinum and a methyl cellulose preparation on the symptoms of dry mouth. Safety and effectiveness of topical dry mouth products containing olive oil, betaine, and xylitol in reducing xerostomia for polypharmacy-induced dry mouth. Evaluation of the clinical efficacy of a mouthwash and oral gel containing the antimicrobial proteins lactoperoxidase, lysozyme and lactoferrin in elderly patients with dry mouth--a pilot study. Subjective and clinical evaluation of oral lubricants in xerostomic patients. The efficacy of Xialine in patients with xerostomia resulting from radiotherapy for head and neck cancer: a pilot-study. Randomized-controlled trial: effect of a reservoir biteguard on quality of life in xerostomia.
This was a prospective, randomized, open, crossover study comparing a mucin-based artificial saliva (Saliva Orthana) with a low-tack, sugar-free chewing gum (Freedent) in the management of xerostomia in patients with advanced cancer. The conclusions of this study were that both Saliva Orthana and Freedent are effective in the management of xerostomia in patients with advanced cancer, that both Saliva Orthana and Freedent cause some side-effects in this group of patients, and that patients with cancer think that chewing gum is an acceptable treatment. Sixty-nine per cent of the patients preferred the chewing gum to the artificial saliva. Furthermore, the chewing gum scored better than the artificial saliva on every measure of efficacy. However, none of these results reached statistical significance. Patients with radiation-induced xerostomia produce little or no saliva. Several studies have demonstrated the efficacy of systemic administration of pilocarpine hydrochloride in individuals with post-radiation xerostomia. However, analysis of pilocarpine lozenges for treatment of post-radiation xerostomia in patients with head and neck cancer has not been reported.
                The aim of this study was to quantify improvement in clinical symptoms and salivary function after treatment of post-radiation xerostomia with pilocarpine lozenges. In a double-blinded, placebo-controlled trial, 33 head and neck cancer patients were assigned randomly to receive Salagen tablet, pilocarpine hydrochloride lozenge (3 or 5 mg) or placebo lozenge every 10 days. At each visit, a subjective evaluation was undertaken through the use of visual analog scales before and at 180 minutes after treatment. Whole resting saliva was collected before and at 0, 30, 60, 90, 120, 150 and 180 minutes after treatment.
                The percentage of patients with decreased feeling of oral dryness, sore mouth or speaking difficulties after taking 5-mg pilocarpine lozenge was greater than Salagen or placebo. There were statistically significant increases in salivary production in pilocarpine treatment groups vs. placebo (P < 0.05).
                The 5-mg pilocarpine lozenge produced the best clinical results, but further investigation with a larger group of patients is required. Five saliva stimulants (Salivin, V6, Mucidan, Ascoxal-T and Nicotinamide) and three saliva substitutes (Saliment, Salisynt and an ex témpore solution) were evaluated in 106 patients with a low salivay flow rate and a long history of dry mouth. The study was carried out as a multi-centre study in collaboration with ten different hospital dental clinics. The participants were interviewed about their complaints related to dry mouth. Each patient was then asked to use the eight saliva stimulants and substitutes for 14 days in a randomized order with one week intervals. After the 14-day-periods, the patients were interviewed about the effect of the various products by a dentist using a standardized questionnaire. Paraffin-stimulated whole saliva samples were collected after each test period. The most serious complaints among the patients were, besides dryness of the mouth, difficulty to talk and difficulty to swallow. The results showed that all eight tested saliva stimulants and substitutes relieved the symptoms of dry mouth to some extent. However, V6 chewing gum and Salivin lozenge were ranked as the two best products by the patients. No long-term effect was found with any of the eight products on the flow rate of paraffin-stimulated whole saliva. This study assessed the efficacy of the Bioxtra (BX) and Biotène Oralbalance (OB) systems in the treatment of post-radiotherapy xerostomia. In a double-blind, crossover study, 20 patients with post-radiotherapy xerostomia were randomly allocated to receive either OB then BX, or vice versa, each product for 2 weeks, with a 1 week wash-out period in between. Subject-based dry mouth scores derived from 100-mm visual analogue scales were recorded at days 0 and 14 of each 2-week period, together with subjective perception of changes in dry mouth symptoms. Both treatments were effective, resulting in reduction of visual analogue scale scores from day 0-14. Between-groups comparisons identified that BX achieved significantly better improvements compared with OB for the perception of dry mouth and improvements in speech and was also rated as more pleasant to use than OB (P < 0.05). In conclusion, both treatments were effective in alleviating the symptoms of post-radiotherapy xerostomia, although BX achieved superiority in some of the outcomes assessed compared with OB. 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. The aim of this study was to determine if radiotherapy induces hyposalivation altering oral microbial flora. The purpose of this placebo-controlled, single-blind study was to determine beneficial effects of a saliva substitute and an oral hygiene product on irradiated patients with oropharyngeal cancer. Eighteen patients were assigned to the test group (Biotène Oral Balance gel [Lacléde Incorporated Healthcare Products, Gardena, CA] and toothpaste used daily), and another 18 were put on a conventional daily regimen (carboxymethylcellulose gel and Oral-B toothpaste [Laclede Pharmaceuticals, Gardena, CA]). Cultures for identifying and quantitating microorganisms, whole unstimulated saliva, and visual analog measurements for comfort were obtained before mucositis occurred and after treatment. Daily use of Biotène products enhanced control of microbial flora, improved salivary flow, and increased oral comfort as compared with control subjects. Four weeks after mucositis, some aerobic isolates disappeared in the test group; periodontal-associated bacteria were markedly decreased in the test group; and candidal species were significantly lowered in the test group. Although baseline saliva was lower in the test group (P = 0.001), after 4 weeks, no difference between groups existed; comfort was greater in the test group (P = 0.007). Use of enzyme-engineered Biotène products that assist in control of the oral microbial flora as well as supporting oral comfort through lubrication appear to be useful aids for irradiated patients with oropharyngeal cancer. To study the effect of mouthrinses with salivary replacement substances on oral conditions in patients with primary Sjögren's syndrome.
                Cross-over, double-blind study.
                Facilities at the Centre for Oral Health Sciences, Malmö University and at Malmö University Hospital, Malmö, Sweden.
                Twenty-two patients with Sjogren's syndrome.
                Linseed extract Salinum alone (Sal) or with addition of chlorhexidine (Sal/Chx) was used for mouthrinsing during 3-week periods of rinsings separated by a 3-week "wash-out" period.
                Recordings of percentages of sites with dental plaque and bleeding on probing, mirror friction test and microbiological analyses. Questionnaire on oral symptoms due to reduced salivation.
                Dental plaque and bleeding on probing were reduced after Sal and after Sal/Chx. Friction was reduced after both treatments. No significant differences for counts of studied microbial groups were seen after Sal but the total anaerobically cultured microorganisms and of mutans streptococci fell after Sal/Chx (p<0.05 and p<0.001). Symptoms of oral dryness improved following Sal and Sal/Chx (p<0.05 and p<0.001 respectively). Speaking problems and burning mouth symptoms improved after use of Sal (p<0.05).
                Positive effects on symptoms in patients with Sjögren's syndrome were seen after use of Salinum without or with chlorhexidine. Application of physostigmine to the oromucosal surface with the aim of stimulating underlying mucin-producing glands while reducing cholinergic systemic effects might be a strategy for treating dry mouth. Subjects suffering from dry mouth and with hyposalivation participated in a crossover, double-blind, randomized study. A gel containing physostigmine (0.9, 1.8, 3.6, and 7.2 mg) or placebo was applied to the inside of the lips and distributed with the tongue. The feeling of dryness was assessed using a visual analogue scale (VAS) (where a score of 100 = extremely dry) and systemic effects were registered. Based on assessments of efficacy and safety, the dose of 1.8 mg of physostigmine was selected for use in the second part of the study to make objective measurements of saliva volumes. Physostigmine (1.8 mg) produced long-lasting (120 min) relief (evident as a score reduction of 25 on the VAS) in the feeling of dryness. Judging from AUC values related to baseline over 180 min, the improvement for both mouth and lips in response to physostigmine was six times greater than that to placebo. At higher doses of physostigmine, gastrointestinal discomfort predominantly occurred. The volume of saliva collected in response to physostigmine was five times higher over 180 min than that collected in response to placebo. Physostigmine, applied locally, therefore appears to be a promising modality for dry-mouth treatment. In elderly individuals the saliva production is often decreased, leading to dry mucosal membranes and predisposition to local infections, as well as other oral problems. Eighty-five hospitalized geriatric patients, with a multitude of disabling diseases, participated in a double blind placebo-controlled study when mucin-containing artificial saliva and a placebo liquid was given. In the patients treated with the artificial saliva a considerable improvement in the condition of oral mucosa was seen. Also, in one quarter of the patients treated with the placebo liquid, the oral candida infection disappeared, possibly due to improved oral hygiene. It is reasonable to assume that general well-being increases when the condition of the oral mucosa improves. If factors causing dry mouth cannot be removed, i.e. due to diseases or ageing factors, treatment with artificial saliva could be of benefit, but the importance of good oral hygiene must not be overlooked. nan 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. Two new saliva stimulants: V6 and a mucin containing chewing gum were tested in this placebo-controlled double-blind crossover study. Forty-three patients (mean age 63 yr) complaining of dry mouth participated. The products were administered in a randomized order, and used for 2 wk each. The effect was evaluated by interviews and by determining changes in stimulated and unstimulated saliva flow rates. A positive effect was reported by 64%, 44%, and 26% of the patients using the mucin chewing gum, V6, and the placebo, respectively. More than 2/3 of the patients found the mucin chewing gum efficient at various times and situations. Sixty-one percent of the patients preferred the mucin chewing gum, 21% V6, and 5% the placebo product. Fifty percent of the patients had an increase in unstimulated salivary secretion rate from all products after 14 days regular use indicating a long-term effect. To compare an intra-oral device to relieve oral dryness with the other methods of lubricating the mouth at night.
                Multidisciplinary single blind randomised cross over study.
                The subjects were drawn from patients attending a dry mouth clinic.
                Thirty-four dentate subjects attended on five occasions at intervals of 4 weeks. At the first visit the teeth were scaled and impressions were recorded. The device was fitted either on the second or the fourth visit. At all visits samples were taken of the resting and stimulated saliva for volumetric analysis and the dry mouth score recorded. Data were collected from the lubrication timings and the questionnaire.
                Ten water, nine saliva substitute and ten sugar-free chewing gum lubricators completed the study. There were 27 female and two male subjects with an average age of 62 years. Nine out of 10 of those lubricating with chewing gum preferred wearing the device (P = 0.037). After the device wearing period the subjects' self assessment of mouth dryness (P = 0.056), speech (P = 0.009) and swallowing (P = 0.031) were more favourable when compared with the alternative lubrication with 66% preferring the intra-oral device to their alternative method of lubrication.
                The majority of the subjects preferred wearing the device at night compared with their normal method of lubrication. Subjects' perception of dryness, speech and swallowing became closer to the clinician's assessment after wearing the device. 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 first-ever controlled study of a therapeutic modality for xerostomia is reported. A recently described formulation for saliva substitute (SS) has been tested against a glycerine mouthwash as a control saliva substitute (placebo) in a double-blind clinical trial in 108 patients with varying grades of xerostomia of Sjögren's syndrome. The results indicate that SS offered significant relief of nocturnal oral discomfort (p less than 0.02) and more patients reported "excellent" improvement (p less than 0.01) on a five-point graded response. In all other respects, the SS was not significantly better than the placebo. Significant adverse effects were not reported. It is suggested that any such current and future therapeutic modalities for Sjögren's syndrome be subjected to similar critical appraisal of their worth. The stimulatory effect of a recently introduced saliva substitute (Saliment) on the parotid salivary secretion was experimentally investigated in 10 healthy individuals without signs or symptoms of xerostomia and in 11 patients with xerostomia due to Sjögren's syndrome. Further, in 15 patients with Sjögren's syndrome, the effect of Saliment on the sensation of xerostomia was examined in a double-blind clinical study with cross-over. The use of Saliment was followed by a significant stimulation in the parotid salivary secretion (P less than 0.01) and the subjection sensation of xerostomia was significantly reduced (P less than 0.01). The effect of multiple daily applications of a prophylactic gel, with buffering substances, on plaque acidogenicity in elderly institutionalised individuals was evaluated.
                Many elderly suffer from reduced salivary flow, poor oral hygiene and increased levels of cariogenic bacteria and are considered to be at an increased risk for coronal and root caries. Reinforcing the buffering capacity of dental plaque by the addition of substances such as bicarbonate and phosphates may decrease their caries activity.
                Fourteen elderly, with subjective dry mouth, were treated for 16-day-periods at random with: (i) Profylin fluoride gel with buffering components; (ii) Profylin fluoride gel without buffering components and (iii) rinsing with water. Applications were made four times a day and each period was followed by a 2-week wash-out period. The plaque pH was registered after a carbohydrate challenge and the following were recorded before and after each test period: stimulated salivary secretion rate, buffer capacity, number Colony Farming Units (CFU) mutans streptococci, lactobacilli and a sample of Candida albicans on oral mucosa.
                Eleven participants (mean age 76.6 years) fulfilled the study. Changes in plaque pH measurements, when calculated as area under the curve (AUC(6.2) and AUC(5.7)) values (pH x min), before and after each of the three treatments, showed no significant differences. A tendency to a higher plaque acidogenicity and amount of cariogenic microorganisms was found after the gel treatments. C. albicans was found in low levels.
                Frequent applications of the gel did not result in an improved neutralising effect in the elderly. This may be caused by a combination of several factors, such as the level of oral dryness of the individuals and low solubility, release and retention of the gel substances in plaque. Instead, an increased plaque acidogenicity was noted. A new chewing gum (PTC) with the ability to release flavoring substances for a rather long time was tested for its ability to stimulate saliva secretion. The chewing gum is mildly flavored and contains non-cariogenic sweeteners (xylitol and sorbitol). Measurements of saliva secretion rate and oral mucosal sliding friction and subjective evaluations on visual analog scales were made in relation to chewing and compared with those when chewing a commercially available gum (V6). The study was a randomized, crossover comparison with blind evaluation. Both chewing gums stimulated saliva secretion and decreased oral mucosal friction. The PTC gum gave consistently higher mean values of saliva secretion rate and lower oral mucosal friction values than V6. The difference was statistically significant for the saliva secretion rate and most pronounced after 5-10 min of chewing. There was also a statistically significant difference between the subjective evaluations of V6 and PTC with regard to saliva-stimulating ability and taste in favor of the PTC gum. Our aim was to study the effects of mildly flavoured sodium lauryl sulphate (SLS)-containing and detergent-free toothpastes with and without betaine (BET) on subjective symptoms of dry mouth in a randomised clinical trial. BET is an osmoprotectant that reacts with molecules to supply the surface with a water coating that protects cells from surfactants. Twenty-seven xerostomic patients and 18 healthy controls took part in the randomised, double-blind clinical trial with a crossover design. Three mildly flavoured toothpastes: (1) 4% BET, (2) 1% SLS and 4% BET, and (3) 1% SLS were used for six weeks each. The reference or washout paste contained neither SLS nor BET. The subjects' dental appointments were at the beginning of the trial and before and after the use of each toothpaste. At each appointment, the subjects were interviewed about subjective sensations of dry mouth (Visual Assessment Scoring (VAS) Index). The subjects did not report any adverse effects in connection with the use of the toothpastes. The VAS scores for lip dryness and eating difficulties were significantly lower for the BET paste (lip dryness: BET<BET+SLS; p < 0.005 and eating difficulties: BET<BET+SLS; p = 0.02; BET<reference; p = 0.003). The BET paste relieved dry mouth symptoms in 44% of the xerostomic patients, the corresponding figures for the other pastes being BET+SLS 22% (p = 0.002 as compared with BET), SLS 18% (p = 0.022), and reference 7% (p = 0.000). In conclusion, all the mildly flavoured toothpastes used in this study were well accepted by the xerostomic subjects. Thus, other toothpaste components may be more mucosa-irritating than just SLS, or else they enhance the effect of SLS. The detergent-free, BET-containing toothpaste appeared to be associated with relief of some symptoms of dry mouth. 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. A randomized clinical trial (Study 1) and consumer usage test (Study 2) were conducted to evaluate the acceptability and efficacy of OASIS Mouth Moisturizing Spray in subjects experiencing dry mouth.
                Study 1: A randomized, single-blind, four-arm crossover clinical trial was conducted in 24 subjects, ranging from 50-84 years of age, to evaluate OASIS Mouth Moisturizing Spray and two experimental mouth spray formulations, and compare their performance to a reference (marketed) mouth spray, SALIVEZE. Following a three-day acclimatization phase, subjects used all four products at home for three days. Each treatment phase was separated by a three-day washout period. Study 2: One-hundred twenty subjects participated in a three-week home usage consumer test using OASIS Mouth Moisturizing Spray, after which they completed a 52-question online survey exploring sensory, efficacy, and resultant quality of life attributes of the product.
                Study 1: On average, subjects used the four test products 2-3 times per day. OASIS Mouth Moisturizing Spray was found to be effective in relieving dry mouth in the study population, as evidenced by a statistically significant feeling of coating the mouth (p < 0.05), and statistically significantly longer dry mouth relief (p < 0.005) than the commercial control. The OASIS Mouth Moisturizing Spray was statistically significantly (p < 0.05) better and preferred over the other product tested. All the products used in the study were well-tolerated. Study 2: On a five-point scale, 73% of respondents perceived the OASIS Mouth Moisturizing Spray as "very good" or "excellent," and more than 60% gave the product an "excellent" or "very good" rating on sensory, efficacy, and quality of life attributes.
                These studies show that OASIS Mouth Moisturizing Spray helped provide dry mouth relief and was well liked by the study population. A comparison was made of Oral Balance gel delivered by slow release via a novel intra-oral device versus an oral bolus of gel on the oral health condition and oral health-related quality of life (OHRQoL) in patients who had received standard head and neck irradiation for nasopharyngeal carcinoma. Twenty-two participants took part in a randomized single-blind crossover clinical study. Each treatment lasted 4 weeks with an intervening 4 weeks washout period. The GOHAI, Xerostomia Inventory and patient satisfaction measures were self-completed and oral health condition assessed objectively at baseline (week 0) and weeks 4, 8 and 12. Oral Balance gel, in bolus and slow-release forms, was effective in improving aspects of oral health, notably a reduction in oral cariogenic micro-organisms. Slow release of gel via the intra-oral device did not appear to improve OHRQoL whereas gel alone reduced the severity of xerostomia symptoms and was the treatment of choice. Irreversible hyposalivation is a common sequela of Sjögren's syndrome and may lead to a decreased quality of the patient's life. The aim of this study was to evaluate the efficacy and therapeutic value of mucin-containing lozenges in reducing patients' complaints of hyposalivation. In a double-blind crossover trial in 42 patients with Sjögren's syndrome, the efficacy and therapeutic value of both a mucin-containing and placebo lozenge were assessed by means of self-administered questionnaires, which had to be completed before and after the use of each type of lozenge for a period of 2 weeks. Seventy-six percent of the patients preferred the mucin lozenge, 10% preferred the placebo, and 14% had no preference. In reducing patients' complaints, sucking the mucin lozenge resulted in a larger improvement of the total pattern of complaints and the sensation of oral dryness, and in a longer moistening of the oral cavity than the placebo. Oral functioning was improved after the use of the placebo, and the patients reported the taste of the placebo to be better than the mucin lozenge. From the responses it was concluded that the use of the mucin lozenges can be recommended in the treatment of oral symptoms of xerostomia. 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. 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. Following therapeutic irradiation of the head and neck, patients with profound xerostomia have complaints associated with oral dryness, effects upon use of oral prosthesis, speech, and taste. In addition, xerostomia may lead to risk of oral infections and rampant demineralization of teeth. The use of topical Oral Balance gel and Biotene toothpaste (Laclede Professional Products, Gardena, CA) versus carboxymethylcellulose gel and commercial toothpaste applications was assessed in a 2-week double-blind, crossover design. The palliative effects of Oral Balance gel and Biotene toothpaste were superior to the effects of a placebo. No effect on oral colonization by Candida species and cariogenic oral microflora was seen with use of the topical agents. Xerostomia is an important chronic side effect of radiotherapy in the head and neck area. The authors investigated the efficacy of different artificial saliva compounds in patients with postirradiation xerostomia.
                In 120 patients with xerostomia after radiotherapy for head and neck cancer, four different saliva substitute compounds (gel, carmellose spray, oil, mucin spray) were tested in a prospective crossover design. Xerostomia at baseline and under treatment with each compound was measured with a questionnaire approved in a pilot trial.
                All compounds significantly improved xerostomia when compared to baseline situation (p < 0.0001). The gel was rated best, the carmellose spray was rated worst by the patients, but the single compounds did not differ significantly in their effects. In spite of this result, most patients chose the carmellose spray as their favorite compound. This is due to its good taste and easy handling, which play an important role for the acceptance of the products. Big individual differences in the preference of the single compounds were found.
                For most patients considerable relief from xerostomia can be reached by saliva substitutes. Thus, every patient with xerostomia should be given different artificial saliva compounds for a test period. This will help to find the individually best way to cope with the dry mouth. 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. A double-blind, five phase, cross-over clinical trial was used to compare a mucin-based artificial saliva (Saliva Orthana) with its non-mucin base and water. Thirty patients, acting as their own controls, took part. Saliva Orthana offered significantly greater relief from xerostomia compared with its base or water, and was significantly better at relieving soreness than water. In terms of overall preference, it was ranked significantly higher than either alternative. Dry mouth is a frequent complaint of adults worldwide. In those who experience dry mouth, therapeutic options include the use of salivary substitutes and sialogogues.
                The authors compared the efficacy and safety of mucoadhesive disks (OraMoist, Axiomedic, Zurich; distributed by Quantum Health, Eugene, Ore.) applied three times daily with those of placebo mucoadhesive disks in a double-masked, randomized, controlled crossover study. The primary end point of interest was within-participant differences in subjective (visual analog scale) ratings of dry mouth according to the New York University Bluestone Mouthfeel Questionnaire. The secondary end point was within-participant differences in salivary flow rates.
                Twenty-seven participants completed the single-site study. The results showed no significant difference between the two types of mucoadhesive disks, both of which were associated with a statistically significant improvement in the subjective experience of moistness across the 60-minute period after application and compared with baseline measures after two weeks of use. Furthermore, both disks were associated with a statistically significant improvement in salivary flow rates across the 60-minute period after application and compared with baseline measures after one and two weeks of use. The disks were well tolerated, and participants did not report any adverse events.
                The mucoadhesive disks used in this study were safe and provided symptomatic relief from dry mouth. Practice Implications. Patients with dry mouth may benefit from this novel delivery system. The effect of a linseed extract Salinum and a sodium carboxymethyl cellulose preparation called MAS-84 was compared with regard to its effect on the symptoms of dry mouth. Twenty patients with xerostomia, who had been treated for cancer in the head and neck by radiation were recruited from the clinic for maxillofacial surgery, Malmo University Hospital. Following radiation treatment the salivation was severely reduced. The symptoms of a general feeling of a dry mouth, difficulties in chewing and swallowing, taste disturbances, problems with speech and mouth burning were registered on a subjective verbal rating scale. In addition plaque index and gingival bleeding were determined. The study design was crossover and performed single blind. The experimental period was 7 weeks. The patients were randomly divided into 2 groups. One group used Salinum and the other MAS-84 for 3 weeks. The fourth week was a wash out period and for the next three weeks the patients shifted preparation. Each of the preparations was used ad libitum. Registrations of the various parameters were undertaken on days 0, 7 and 21 of the respective period. At the initial examination all patients reported considerable disturbances from mouth-dryness. These symptoms were reduced in 15 patients during the Salinum period and in 9 during the MAS-84 period. The relief was significantly more pronounced during the use of Salinum compared to that during the use of the methyl cellulose preparation. On day 21 plaque and gingival bleeding were significantly reduced during the Salinum period but not during the MAS-84 period. The results of the present study confirm those of a previous pilot study and indicate that the linseed mucilage significantly reduced the symptoms of dry mouth. This effect increased with increasing time of saliva substitute use. The linseed mucilage Salinum appeared to be a suitable saliva replacement in mouth dry patients. 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. To evaluate the clinical efficacy of a mouthwash and oral gel containing the antimicrobial proteins lactoperoxidase, lactoferrin and lysozyme, in a sample of elderly individuals with dry mouth.
                Twenty elderly institutionalised subjects with dry mouth and with a certain degree of independence for daily life activities were included in this pilot study. A randomised, double blind and cross-over design was used. The study variables comprised subjective dry mouth sensation, the severity of discomfort assessed by means of a visual analogical scale (VAS), the Oral Health Impact Profile (OHIP), the presence of signs and symptoms of dry mouth, sialometry and Candida albicans culture. All the variables were recorded before and after each of the two periods of the study.
                The 20 selected subjects we made up of 16 women and four men, with a mean age of 81.3 years. Improvement was observed on analysing the data between the first and second intervention period in terms of the OHIP values, the presence of dry mouth, and the need to drink fluids to swallow. However, the improvement in certain variables before and after treatment did not take a positive course in all cases, and some subjects even improved with placebo.
                The evaluated mouthwash and oral gel improved some subjective and clinical aspects in elderly individuals with dry mouth, though a placebo effect cannot be entirely discarded. 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. Changes in subjective sensations due to xerostomia before and after administration of Xialine, a xanthan gum-based saliva substitute, were evaluated in 30 patients with radiation-induced xerostomia using the QLQ-H&N35. Xerostomia in general decreased with both Xialine and placebo to almost the same degree. A trend was seen for Xialine to improve problems with speech and senses. To assess the effect of a reservoir biteguard for artificial saliva on the oral health-related quality of life of patients with xerostomia.
                Double-blind randomized placebo-controlled trial among 86 adults with xerostomia. Study group received the trial biteguard. Control group received a conventional biteguard. Outcomes were number of impacts and total scores as recorded by oral impacts on daily performances (OIDP).
                At 1-month follow up 84 people remained in the trial. The median number of impacts in the study and control groups was 3 and 4 respectively. The median total score was 6 and 12 respectively. In ANCOVA receipt of the reservoir biteguard reduced the number of impacts recorded by OIDP but there was no difference in the total score.
                Reservoir biteguards improved the quality of life of people with xerostomia by reducing the number of impacts on daily life.
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.