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 Sjögren'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 ClinicalTrials.gov identifier: NCT00509808. Drs.

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Temporomandibular disorders (TMD) have been associated with altered salivary oxidative status, but the relation with pain source and pain severity isn’t clarified. With the aim to assess their interaction with TMD, we compared levels of selected salivary oxidative stress (OS) markers (glutathione peroxidase, superoxide dismutase, total antioxidant capacity (TAC), uric acid, 8-hydroxydeoxyguanosine, malondialdehyde) and salivary cortisol (SC) as a stress indicator, between 20 TMD patients and 15 healthy control subjects. In order to record differences relating to pain source and severity, patients were respectively classified according to specific diagnoses (myofascial pain or disc displacement (DD)), and pain intensity (high or low). TAC was significantly higher in TMD patients than in controls (morning p = 0.015; afternoon p = 0.005). Significant differences were also observed when TAC levels between high-intensity pain patients and controls were compared, as well as between DD patients and controls. In logistic regression analysis, higher levels of TAC were related to DD (morning OR: 1.66, 95%CI: 1.05–2.64, p = 0.029; afternoon OR: 2.10, 95%CI: 1.11–3.98, p = 0.021) and to high-intensity pain (morning OR: 1.81, 95%CI: 1.04–3.15, p = 0.037; afternoon OR: 1.79, 95%CI: 1.02–3.14, p = 0.043). We also found that morning SC was positively correlated with antioxidant parameters in TMD patients. Our data suggest compensatory mechanism as response to higher level of stress. This stress could be extrinsic and lead toward TMD, or intrinsic, emerging from established TMD, or could be both. The intensity and the source of pain should be considered important factors in future investigations evaluating salivary OS markers in TMD patients.

The present study evaluated diurnal variations and day-to-day fluctuations of salivary oxidative stress (OS) markers in healthy adult individuals. Whole unstimulated saliva was collected at 2 time intervals over 3 consecutive days. Glutathione peroxidase (GPX), superoxide dismutase (SOD), total antioxidant capacity (TAC), and uric acid (UA) were analyzed using spectrophotometric methods, while 8-hydroxydeoxyguanosine (8-OHdG) and malondialdehyde (MDA) were determined using immunoassays. No significant differences for salivary OS markers between men and women were observed. For all examined OS markers, no significant day-to-day variations were demonstrated. Significant diurnal variations were found in salivary GPX, TAC and MDA levels. For SOD, TAC, GPX, and UA, good-to-moderate intraindividual coefficients of variations (CVs) were observed in more than 75% of the subjects. For MDA and 8-OHdG, intraindividual CVs > 35% were observed in 60% and 40% of the subjects, respectively. Between-subject variance was wide for all examined OS markers (CV% 30.08%–85.70%). Due to high intraindividual variability in the salivary concentrations of MDA and 8-OHdG, those markers cannot be reliably verified based on single measurements and multiple measurements over several days would provide more reliable information. Salivary SOD, TAC, GPX, and UA proved stable across three days of measurement. Trial Registration. ClinicalTrials.gov NCT03029494. Registered on 2017-01-19.

have their natural teeth and maintain good oral hygiene. Participants were not suitable if they were experiencing (1) inflammatory joint disease, (2) orofacial pain unrelated to TMD, (3) chronic systemic diseases (i.e. diabetes, cardiovascular diseases, malignancies, and autoimmune diseases), (4) causes of headache, unrelated to TMD, listed in the International Classification of Headache Disorders (ICDH II), (5) periodontitis, oral lesions and gum swelling. Individuals who had already been under treatment for TMD were excluded. Finally, participants who use supplements and medication known to affect the oxidative status, and smoke were not able to take part in the study. Study design. Allocation. To reduce the waiting time and potential withdrawal until a sufficient number of participants are involved, we have chosen a randomization procedure based on our experience of enrolling 6-8 participants in 2 months. The patients were assigned into two treatment groups utilizing random block randomization with a block size of 8 and 6. Randomization was computer-generated, and participants were randomly assigned to two treatment arms, SS or PS. The allocation was prepared by the study's statistician prior to enrollment of the participants. Blinding. Participants were unaware of the differences of each intervention. The principal investigator (IZA), who conducted the baseline evaluations, was the only person aware of the participants' treatment conditions. All follow-up assessments were performed by the investigator (EV), blinded to the group allocation. Observer training. Ten randomly selected subjects, different from the ones included in the investigation, underwent repeated clinical examinations by two experienced examiners to assess signs and symptoms of TMD (according to DC/TMD). No significant differences were recognized between the first and the second measurements (p = 0.87-0.89, paired t-test). The weighted kappa statistics showed adequate agreement between the observers (κ = 0.86-0.88).