Pilocarpine and artificial saliva for the treatment of xerostomia and xerophthalmia in Sjögren syndrome: a double-blind randomized controlled trial.

BACKGROUND: Sjögren syndrome (SS) is associated with xerostomia and xerophthalmia. Pilocarpine has been shown to stimulate the secretion of saliva. OBJECTIVES: To investigate and compare the efficacy of pilocarpine and artificial saliva as symptomatic treatments for xerostomia and xerophthalmia in patients with SS. METHODS: A double-blind randomized controlled study was performed. A total of 72 patients with SS were assigned randomly to receive 10 drops of pilocarpine (5 mg) or 10 drops of artificial saliva orally, three times daily for 12 weeks. Whole saliva and tear flow were evaluated at baseline and periodically throughout the study to provide a global assessment of dryness and to report any adverse effects. RESULTS: Patients receiving pilocarpine had a statistically significant improvement in their salivary flow (P < 0·001), lacrimal flow (P < 0·001) and their subjective global assessment (P < 0·001), compared with patients who received artificial saliva. The most common side-effects were sialorrhoea and nausea. CONCLUSIONS: Pilocarpine is more effective than artificial saliva for enhancing salivary and lacrimal secretion in patients with SS. This is the first study to compare the efficacy of pilocarpine and artificial saliva for the treatment of xerostomia and xerophthalmia in SS.

Erosion protection by calcium lactate/sodium fluoride rinses under different salivary flows in vitro.

This study investigated the effect of a calcium lactate prerinse on sodium fluoride protection in an in vitro erosion-remineralization model simulating two different salivary flow rates. Enamel and dentin specimens were randomly assigned to 6 groups (n = 8), according to the combination between rinse treatments - deionized water (DIW), 12 mM NaF (NaF) or 150 mM calcium lactate followed by NaF (CaL + NaF) - and unstimulated salivary flow rates - 0.5 or 0.05 ml/min - simulating normal and low salivary flow rates, respectively. The specimens were placed into custom-made devices, creating a sealed chamber on the specimen surface connected to a peristaltic pump. Citric acid was injected into the chamber for 2 min, followed by artificial saliva (0.5 or 0.05 ml/min) for 60 min. This cycle was repeated 4×/day for 3 days. Rinse treatments were performed daily 30 min after the 1st and 4th erosive challenges, for 1 min each time. Surface loss was determined by optical profilometry. KOH-soluble fluoride and structurally bound fluoride were determined in specimens at the end of the experiment. Data were analyzed by 2-way ANOVA and Tukey tests (α = 0.05). NaF and CaL + NaF exhibited significantly lower enamel and dentin loss than DIW, with no difference between them for normal flow conditions. The low salivary flow rate increased enamel and dentin loss, except for CaL + NaF, which presented overall higher KOH-soluble and structurally bound fluoride levels. The results suggest that the NaF rinse was able to reduce erosion progression. Although the CaL prerinse considerably increased F availability, it enhanced NaF protection against dentin erosion only under hyposalivatory conditions.

Evaluation of the efficacy of a topical sialogogue spray containing malic acid 1% in elderly people with xerostomia: a double-blind, randomized clinical trial.

OBJECTIVE: The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid for elderly people affected by xerostomia. MATERIAL AND METHODS: This research took the form of a double-blind, randomized clinical trial. Forty-one individuals (mean age: 78.7 years) with xerostomia were divided into two groups: for the first 'intervention group' (21 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second 'control group' (20 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The Xerostomia Inventory (XI) was used to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after spray application, were measured. RESULTS: XI scores decreased significantly (clinically meaningful) from 36.4 ± 7.3 points to 29.1 ± 7.1 (p < 0.05) with an XI difference of 7.2 ± 6.1, after the combination among 1% malic acid with xylitol and fluoride application. After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < 0.05). CONCLUSION: A topical sialogogue spray containing 1% malic acid improved xerostomia in an elderly population and increased unstimulated and stimulated salivary flows rates.

Low toxic effects of a whitening strip to cultured pulp cells.

PURPOSE: To assess the trans-enamel and trans-dentin toxicity of a 10% hydrogen peroxide (HP) whitening strip to odontoblast-like cells (MDPC-23). METHODS: Enamel surfaces of enamel/dentin discs adapted to artificial pulp chambers were subjected to two 30-minute whitening strip applications to obtain indirect extracts (DMEM + bleaching components that diffused across enamel and dentin). The extracts were applied for 1 hour to the cells for 1 or 5 days. A bleaching gel with 35% HP was used as the positive control. Cell viability (MTT assay) and morphology (SEM) as well as the quantity of HP in the extracts were assessed. RESULTS: Discrete cell viability reduction (21.9%) associated with slight alterations in cell morphology occurred after application of the extracts for 5 days to the MDPC-23 cells (Tukey's test; P < 0.05). Lower enamel/dentin diffusion of HP was observed after the use of the whitening strip compared with the bleaching gel (Mann-Whitney; P < 0.05).

Oral health promotion interventions on oral yeast in hospitalised and medically compromised patients: a systematic review.

Yeast are major aetiological agents of localised oral mucosal lesions, and are also leading causes of nosocomial bloodstream infections. The purpose of this systematic review was to examine the effectiveness of oral health promotion interventions on the prevalence and incidence of these opportunistic oral pathogens in hospitalised and medically compromised patients. The PubMed, ISI Web of Science and Cochrane Library databases were searched for clinical trials assessing the effect of oral health promotion interventions on oral yeast. Chlorhexidine delivered in a variety of oral hygiene products appeared to have some effect on oral yeast, although some studies found equivocal effects. Although a wide array of other compounds have also been investigated, their clinical effectiveness remains to be substantiated. Likewise, the utility of mechanical oral hygiene interventions and other oral health promotion measures such as topical application of salivary substitute, remains unsettled. Although many chemical agents contained in oral hygiene products have proven in vitro activity against oral yeast, their clinical effectiveness and potential role as adjuncts or alternative therapies to conventional treatment remains to be confirmed by further high-quality randomised controlled trials. This is pertinent, given the recent emergence of yeast resistance to conventional antifungal agents.

Management of a post-radiotherapy xerostomic patient--a case report.

OBJECTIVE: The objective of the study was to fabricate complete denture with palatal reservoir filled with artificial saliva for a post radiotherapy edentulous patient. BACKGROUND: Xerostomia is a subjective complaint rather than a disease. It is caused by irradiation, medication, Sjogren's syndrome & neurological factors such as stress. Radiotherapeutic treatment of head and neck cancer patients often causes long term dysfunction involving their salivary function, swallowing capabilities & taste. All three of these domains are affected by radiation- induced damage to the salivary glands. This in turn results in poor retention of complete denture, frequent trauma to alveolar ridge & other oral infections. All these events drastically affects quality of life of ageing patients. MATERIAL AND METHOD: A complete denture in heat cure acrylic resin was fabricated in which a palatal reservoir was made on the palatal side. RESULTS: Problems arising due to xerostomia were reduced to a great extent. CONCLUSION: Prosthodontic management of Xerostomic patient include several techniques. This paper presents a case report of post radiotherapy edentulous patient in which complete denture with palatal reservoir filled with artificial saliva was fabricated.

XyliMelts time-release adhering discs for night-time oral dryness.

Dry mouth can be caused by medication, CPAP use, radiation treatment and a variety of connective tissue diseases, with the prevalence increasing with age. In most individuals, daytime dryness is easily managed. However, except for a new product tested in this study, there is no product lasting longer than an hour that can be used at night to reduce the perception of oral dryness while sleeping. The purpose of this study was to assess whether a self-adhering, slowly dissolving disc that time-releases 500 mg of xylitol, cellulose gum (lubricant and humectant) and mild mint flavour (XyliMelts for Dry Mouth, OraHealth Corp.) used during sleep would reduce perceived morning oral dryness and discomfort. Fifteen subjects self-identified as having morning oral dryness were evaluated first without treatment and again with the use of XyliMelts for Dry Mouth. Measures of initial morning discomfort and perceived wetness demonstrated significant improvement. Perceived oral wetness scores increased more than threefold with the use of XyliMelts for Dry Mouth while sleeping. These findings suggest that XyliMelts for Dry Mouth may be an effective strategy for managing oral dryness that occurs at night.

Interventions for the management of dry mouth: topical therapies.

BACKGROUND: Xerostomia (the feeling of dry mouth) is a common symptom especially in older adults. Causes of dry mouth include medications, autoimmune disease (Sjögren's Syndrome), radiotherapy or chemotherapy for cancer, hormone disorders and infections. OBJECTIVES: To determine which topical treatments for dry mouth are effective in reducing this symptom. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group Trials Register (28 October 2011), The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 4 2011), MEDLINE via OVID (1950 to 28 October 2011), EMBASE via OVID (1980 to 28 October 2011), CINAHL via EBSCO (1980 to 28 October 2011), AMED via OVID (1985 to 28 October 2011), CANCERLIT via PubMed (1950 to 28 October 2011). SELECTION CRITERIA: We included randomised controlled trials of topical interventions such as lozenges, sprays, mouthrinses, gels, oils, chewing gum or toothpastes for the treatment of dry mouth symptom. We classified interventions into two broad categories, saliva stimulants and saliva substitutes, and these were compared with either placebo or another intervention. We included both parallel group and crossover trials. DATA COLLECTION AND ANALYSIS: Two or more review authors independently carried out data extraction and assessed risk of bias. Trial authors were contacted for additional information as required. MAIN RESULTS: Thirty-six randomised controlled trials involving 1597 participants met the inclusion criteria. Two trials compared saliva stimulants to placebo, nine trials compared saliva substitutes to placebo, five trials compared saliva stimulants directly with saliva substitutes, 18 trials directly compared two or more saliva substitutes, and two trials directly compared two or more saliva stimulants. Only one trial was at low risk of bias and 17 were at high risk of bias. Due to the range of interventions, comparisons and outcome measures in the trials, meta-analysis was possible for only a few comparisons. Oxygenated glycerol triester (OGT) saliva substitute spray shows evidence of effectiveness compared to an electrolyte spray (standardised mean difference (SMD) 0.77, 95% confidence interval (CI) 0.38 to 1.15) which corresponds to approximately a mean difference of 2 points on a 10-point visual analogue scale (VAS) for mouth dryness. Both integrated mouthcare systems (toothpaste + gel + mouthwash) and oral reservoir devices show promising results but there is insufficient evidence at present to recommend their use. Although chewing gum is associated with increased saliva production in the majority of those with residual capacity, there is no evidence that gum is more or less effective than saliva substitutes. AUTHORS' CONCLUSIONS: 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.

Effects of saliva substitutes on oral status in patients with Type 2 diabetes.

AIMS: To assess oral status in a sample of Type 2 diabetic patients before and after therapy with saliva substitutes and oral status in a control group of diabetic patients who were not given saliva substitutes. METHODS: Salivary flow rate was determined in 134 patients (mean age 47.9 ± 2.9 years) with Type 2 diabetes. Mean salivary rate was significantly low compared with a healthy control group. The sample of 134 patients was randomly divided into two groups of 67 people each. One group was given immunologically active salivary substitutes for 6 months, the other group was given nothing. Each patient of the two groups underwent a dental and periodontal examination at the beginning of the study and 6 months later. RESULTS: As regards carious teeth and teeth loss, there was no statistical difference between the first group after 6 months of treatment with salivary substitutes and the control group (P>0.01). Salivary substitutes did not significantly reduce the periodontal disease (P>0.01). In the group treated with salivary substitutes, after 6 months of therapy, the average dental plaque index decreased from 2.3 ± 0.73 to 1.6 ± 0.56, patients with gingivitis decreased from 66 to 43% and patients with positive yeast counts decreased from 60 to 37%. These differences were statistically significant (P<0.01). CONCLUSIONS: In Type 2 diabetes, in the case of hyposalivation, a therapy with immunologically active saliva substitutes can be of help in reducing the amount of plaque, gingivitis and positive yeast counts.

Effect of different fluoride concentrations of experimental dentifrices on enamel erosion and abrasion.

It has been suggested that fluoride products are able to reduce erosive tooth wear. Thus, the purpose of this in vitro study was to evaluate the effect of dentifrices with different fluoride concentrations as well as of a low-fluoridated dentifrice supplemented with trimetaphosphate (TMP) on enamel erosion and abrasion. One hundred twenty bovine enamel blocks were assigned to the following experimental dentifrices: placebo, 1,100 microg F/g, 500 microg F/g plus 3% TMP and 5,000 microg F/g. The groups of enamel blocks were additionally subdivided into conditions of erosion (ERO) and of erosion plus abrasion (ERO + ABR). For 7 days, the blocks were subjected to erosive challenges (immersion in Sprite 4 times a day for 5 min each time) followed by a remineralizing period (immersion in artificial saliva between erosive challenges for 2 h). After each erosive challenge, the blocks were exposed to slurries of the dentifrices (10 ml/sample for 15 s). Sixty of the blocks were additionally abraded by brushing using an electric toothbrush (15 s). The alterations of the enamel were quantified using the Knoop hardness test and profilometry (measurements in micrometers). The data were analyzed using a 2-way ANOVA test followed by a Bonferroni correction (p < 0.05). In in vitro conditions, the 5,000 microg F/g and 500 microg F/g plus 3% TMP dentifrices had a greater protective effect when compared with the 1,100 microg F/g dentifrice, under both ERO and ERO + ABR conditions. The results suggest that dentifrices alone are not capable of completely inhibiting tooth wear.

[Xerostomia. Improved care using a spray with herbal polysaccharides]. / Xerostomie. Verbesserte Linderung durch ein Spray mit pflanzlichen Polysacchariden.

BACKGROUND: In a prospective clinical study the topical use of a polysaccharide-containing spray for the treatment of xerostomia after radiotherapy in the head and neck area was tested. PATIENTS AND METHODS: A total of 83 patients (evaluable return: n=55) with xerostomia after radiotherapy in the head and neck area received a pump spray with 50 ml Saliva natura (medac, Wedel, Germany) to test for 1 week. The patients were asked to fill in a questionnaire about their xerostomia with and without use of the spray. Individual items included: xerostomia in the state of rest, difficulties speaking, eating and sleeping, frequency of the use of treatment against xerostomia, changes in taste, and saliva viscosity. Additionally, they assessed the spray in general and for taste. RESULTS: Patients reported an improvement in all areas included in the questionnaire. The greatest effect of the spray was seen in sleeping difficulties, which improved by almost a whole point from 3.65 to 2.67, as well as in the frequency of use of xerostomia treatment (averagely 15x/day without and 10x/day with the spray). On average the spray was graded as "satisfactory" (3.09), while its taste was graded as "good" (2.17). CONCLUSION: The tested spray may help improve the situation of patients with xerostomia following radiotherapy in the head and neck area. These patients should be given the opportunity to test a spray of this kind.

Clinical evaluation of a new artificial saliva in spray form for patients with dry mouth.

OBJECTIVES: To determine the efficacy of a new saliva substitute in spray form, for patients with dry mouth. STUDY DESIGN: Thirty-seven patients with dry mouth were selected (16 males and 21 females), with an age of over 60 years and meeting the following inclusion criteria: xerostomia and hyposialia confirmed by sialometry (resting whole saliva / stimulated whole saliva). A new artificial saliva in spray format was applied, with evaluation of the degree of improvement (VAS scale), frequency of application, time to improvement in minutes, duration in minutes, and assessment of organoleptic properties. RESULTS: Twenty of the 37 patients showed almost immediate improvement after application. The mean number of applications/day was 3.89, with a mean duration of effect of 15.3 min. (65% > 15 min.). The flavor was rated as pleasant by 18 patients. CONCLUSIONS: Application of the spray is simple and effective, affording immediate relief, and with reasonable acceptance among patients with dry mouth.

Comprehensive investigation of saliva replacement liquids for the treatment of xerostomia.

The sensation of dry mouth also referred to as xerostomia is becoming increasingly common worldwide. Current treatment strategies include topical agents, sialagogues and saliva substitutes. The latter have been reported to be ineffective as special physicochemical features of natural saliva have so far been ignored (e.g., buffer capacity, osmolality, etc.). The aim of this study was to comprehensively investigate the most relevant physicochemical properties of three products frequently used in the clinics and compare them to unstimulated whole saliva (UWS). Sialin-Sigma®, Glandomed® and Xylitol CVS HealthTM Dry Mouth Spray were characterized regarding their pH, osmolality, electrical conductivity, buffer capacity, rheological behaviour, microstructure, surface tension and wettability and compared to UWS. The influence of residual saliva was examined under consideration of the conditions of xerostomia to assess whether the quantity given in the instruction for use is appropriate. All three products showed significant differences to UWS regarding the values received. Only Xylitol CVS HealthTM Dry Mouth Spray showed a comparable wettability. It could be further determined that the recommended doses were too low. These data can not only be used for an improved understanding of saliva, but also for the development of a replacement fluid to successfully alleviate xerostomia.

The inhibitory effect of MI paste, fluoride and a combination of both on the progression of artificial caries-like lesions in enamel.

This in-vitro study evaluated the inhibition of demineralization in enamel sections produced by MI paste, fluoride and a combination of both, compared to artificial saliva and NaF 5000 ppm in a caries progression pH-cycling model. Twenty-one teeth were demineralized to create subsurface enamel lesions (approximately 200 microns in depth). The teeth were sectioned and characterized using polarized-light-microscopy (PLM). A single section from each lesion was assigned to a treatment group: Artificial saliva, NaF 5000 ppm (Prevident, Colgate), MI paste (Recaldent, GC America Inc), NaF 1100 ppm (Crest, Procter & Gamble) and NaF 1100 ppm plus MI paste. The sections were covered with varnish except for an exposed window on the external surface of the lesion and placed in a six-day pH-cycling model with two daily treatment applications of two minutes each. The sections were characterized by PLM, and the lesion areas were measured using a digital image analysis system. Based on a paired-sample t-test, significant differences (p < .05) in percentage of change in lesion size were found between the high fluoride group and all the other groups. No significant difference was found between the artificial saliva and MI paste group, neither was there any significant difference between the NaF 1100 ppm, the combined application group or the MI paste group alone. In conclusion, the higher concentration of NaF (5000 ppm) reduced lesion progression to the greatest extent. The MI paste group did not show any effect on the inhibition of lesion progression. Further studies on the preventive effect and longer treatment applications are recommended.

An ex vivo salivary lubrication system to mimic xerostomic conditions and to predict the lubricating properties of xerostomia relieving agents.

Advances in medical research has resulted in successful treatment of many life-threatening infectious diseases as well as autoimmune and lifestyle-related diseases, increasing life-expectancy of both the developed and developing world. As a result of a growing ageing population, the focus has also turned on chronic diseases which seriously affect the quality of older patient life. Xerostomia (dry mouth) is one such condition, which leads to bad oral health and difficulty in consumption of dry foods and speech. Saliva substitutes are used to ease symptoms. However, they often don't work properly and objective comparison of saliva substitutes to mimic natural salivary functions does not exist. The study thus aims to develop an ex vivo friction assay simulating dry mouth conditions and facilitating objective comparison of saliva substitutes. A reciprocating sliding tongue-enamel system was developed and compared to a PDMS (polydimethylsiloxane)-PDMS friction system. The tongue-enamel system, but not the PDMS-PDMS model, showed high mucin-containing saliva (unstimulated and submandibular/sublingual saliva) to give higher Relief than mucin-poor lubricants (water, parotid saliva, Dentaid Xeros) and correlated well (r = 0.97) with in vivo mouth feel. The tongue-enamel friction system mimicked dry mouth conditions and relief and seems suited to test agents meant to lubricate desiccated oral surfaces.

Surface microhardness of enamel after different home bleaching procedures.

OBJECTIVES: The purpose of this study was to evaluate the influence of different home bleaching procedures on surface microhardness of human enamel. METHODS: Among eight groups 192 incisors were distributed. The facial surface of each incisor was polished and baseline hardness of enamel (m0; Knoop) was assessed with a load of 1N for 30s. Subsequently, the enamel was treated for 14 days with the bleaching agent: groups 1, 2 and 4 Viva Style Paint on, 8% carbamide peroxide (CP) 1x20min, 2x20min and 2x5min; group 3 Colgate Simply White, 5.9% hydrogen peroxide (HP), 2x30min; group 5 Viva Style 10% CP 1x1h; group 6 Blend-a-med White Strips, 5.9% HP 2x30min; group 7 Odol-med3 Beauty-Kur, sodium chlorite 2x10min; group 8 control, running water 1x1h. Hardness was reassessed after the last bleaching treatment (m1) and after 6 weeks storage in artificial saliva (m2). RESULTS: Changes in microhardness were as follows (m0-m1): (1) -2.3 (+/-20.3); (2) -8.9 (+/-27.2); (3) 63.4 (+/-56.3); (4) 9.6 (+/-30.1); (5) 12.8 (+/-62.6); (6) 92.2 (+/-50.2); (7) 158.4 (+/-59.7); (8) 10.6 (+/-38.5). Statistical analysis showed that hardness values were significantly (p< or =0.0005; Wilcoxon test) reduced in groups 3, 6, and 7 (m1) and in group 7 (m2). SIGNIFICANCE: Both type of bleaching agent and concentration have a significant influence on the microhardness of enamel. The most critical bleaching agent seems to be the one containing sodium chlorite in combination with citric acid.

Effect of various calcium/phosphates ratios of carboxymethylcellulose-based saliva substitutes on mineral loss of bovine enamel in vitro.

OBJECTIVES: The present study evaluated the effects of various calcium and phosphate concentrations and ratios of carboxymethylcellulose (CMC)-based solutions on the mineral loss of predemineralised bovine enamel in vitro. METHODS: Bovine enamel specimens were prepared, polished and partly covered with nail varnish, thus serving as control of sound enamel. After demineralisation (37 degrees C; pH 5.0; 14 days) the specimens were exposed to CMC-based solutions (20g/l) with various saturations with respect to apatites containing 0.1mM NaF, CaCl2 (0-32 mM) and KH2PO4 (0-52 mM) at two different pH values (5.5 or 6.5). A fluoride-free solution served as control, and four commercially available products were tested as well. The differences in mineral loss (DeltaDeltaZ) between the values prior to (DeltaZ Demin) and after storage (DeltaZ Effect) in the various solutions were evaluated from microradiographs of thin sections (100microm). RESULTS: The general linear model revealed a significant dependency for DeltaDeltaZ on 'calcium' (p<0.001), 'phosphate' (p=0.023), 'fluoride' (p=0.002) and 'pH' (p<0.001). With increasing calcium and phosphate concentrations an increase in DeltaDeltaZ could be observed up to the solution containing the third highest saturation with respect to octacalciumphosphate (3.2), showing a significant remineralisation (p<0.05; t-test). The commercially available products as well as the control groups revealed significantly reduced DeltaDeltaZ values compared to this group (p<0.01; Bonferroni). CONCLUSIONS: A saturation with respect to octacalciumphosphate of 3.2 and a pH of 6.5 enables CMC-based solutions to remineralise bovine enamel in vitro.

Facilitated saliva secretion and reduced oral inflammation by a novel artificial saliva system in the treatment of salivary hypofunction.

Saliva substitutes and/or lubricants are commonly employed to lessen dry mouth symptoms by stimulating and/or substituting for the secretion of saliva. In this study, a novel artificial saliva containing inorganic salts, including sodium chloride and potassium chloride, and bactericidal agents, including potassium thiocyanate and lactoperoxidase, was formulated in the form of a solution (DM-sol) or gel (DM-gel). Those in vivo therapeutic efficacies were assessed in terms of saliva secretion and anti-inflammatory activity in rats and mice, respectively. Salivary secretion was promoted by mucosal application of DM-formulations in normal rats. In particular, DM-gel resulted in 2.5- and 1.9-fold greater salivary flow rates compared to normal saline and DM-sol, respectively. In an in vivo efficacy evaluation in diabetic mice with salivary hypofunction, repeated application of DM-formulations alleviated histopathological changes in the buccal mucosa in terms of atrophy and thinning of the epithelium, compared to vehicle, after 4 weeks. Moreover, the DM-sol and DM-gel were comparably effective for relieving periodontal gingivitis, reducing infiltration of inflammatory cells, and normalizing the neutrophil level in the gingival gingiva, after 4 weeks. Therefore, the novel artificial saliva is expected to facilitate salivary secretion and restore physiological conditions in the mouth of patients with salivary hypofunction.

Efficacy of a novel lubricating system in the management of radiotherapy-related xerostomia.

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.