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Objective To evaluate the efficacy and safety of an intraoral electrostimulation device, consisting of stimulating electrodes, an electronic circuit, and a power source, in treating xerostomia. The device delivers electrostimulation through the oral mucosa to the lingual nerve in order to enhance the salivary reflex. Methods The device was tested on a sample of patients with xerostomia due to Sjogren's syndrome and other sicca conditions in a 2-stage prospective, randomized, multicenter trial. Stage I was a double-blind, crossover stage designed to compare the effects of the electrically active device with the sham device, each used for 1 month, and stage II was a 3-month open-label stage designed to assess the long-term effects of the active device. Improvement in xerostomia severity from baseline was the primary outcome measure. Results A total of 114 patients were randomized. In stage I, the active device performed better than the sham device for patient-reported xerostomia severity (P < 0.002), xerostomia frequency (P < 0.05), quality of life impairment (P < 0.01), and swallowing difficulty (P < 0.02). At the end of stage II, statistically significant improvements were verified for patient-reported xerostomia severity (P < 0.0001), xerostomia frequency (P < 0.0001), oral discomfort (P < 0.001), speech difficulty (P < 0.02), sleeping difficulty (P < 0.001), and resting salivary flow rate (P < 0.01). Conclusion Our findings indicate that daily use of the device alleviated oral dryness, discomfort, and some complications of xerostomia, such as speech and sleeping difficulties, and increased salivary output. The results show a cumulative positive effect of the device over the period of the study, from baseline to the end of the trial.

Objective A previous sham-controlled multinational study demonstrated the short-term efficacy and safety for xerostomia treatment of an intraoral device that delivers electrostimulation to the lingual nerve. The objective of this study was to test the hypothesis that those beneficial effects would be sustained over an 11-month period. Study Design The device was tested on a mixed sample of 94 patients with xerostomia in an open-label, uncontrolled, prospective multicenter trial. Statutory outcome assessments were done at 5th, 8th, and 11th months and analyzed by multiple comparisons. Results Improvements achieved at month 5 from baseline were sustained throughout the follow-up period for the primary outcome, xerostomia severity, and the secondary outcomes resting whole salivary flow rate, xerostomia frequency, oral discomfort, and difficulties in speech, swallowing, and sleeping. No significant side effects were detected. Conclusions The beneficial effects of a removable intraoral electrostimulating device were sustained for an 11-month period.

examination followed by the administration of a risk factor questionnaire. A cervical, buccal, occlusal/incisal, and lingual score was recorded for each tooth using a modified version of the Tooth Wear Index (Smith and Knight, 1984). Rank correlations, one-way and two-way ANOVA were used to test for associations between risk factors and percent of surfaces with wear. Results: 44 patients (31.9%) had at least one cervical lesion 1-2mm deep. 118 patients (85%) had dentin exposure on at least one incisal edge. Cervical lesions were most frequently observed on mandibular 1 premolars. Incisal/occlusal wear was most common on mandibular central incisors. Age was significantly correlated with overall wear (r 0.53, P 0.01). Two-way ANOVA indicated an interaction between age and GERD, and separate one-way ANOVAs by age groups showed that, among patients under 44 years of age, those with symptoms of GERD had significantly more wear than those without any symptoms of GERD (P 0.02). No other risk factors were associated with wear. Conclusions: Our data indicate the most prevalent sites of non-carious tooth wear and the frequency of pathological lesions. Age and GERD were shown to be significant risk factors for tooth wear. Future epidemiologic risk factor studies should examine purported risk factors in homogenous age groups. Supported by: NIH/NIDCR T32DE07023.