Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial

Autor: Strietzel, FP, Lafaurie, GI, Bautista Mendoza, GR, Alajbeg, I, Pejda, S, Vuletic, L, Mantilla, R, Falcao, DP, Leal, SC, BArreto Bezerra, AC, Tran, SD, Menard, HA, Kimoto, S, Pan, S, Martin Granizo, Maniegas Lozano, L, RA, Zunt, SL, Krushinski, CA, MELILLI, Dario, CAMPISI, Giuseppina, PADERNI, Carlo, Dolce, S, Yepes, JF, Lindh, L, Koray, M, Mumcu, G, Elad, S, Zeevi, I, Aldape Barrios, BC, Lopez Sanchez, RM, Beiski, BZ, Wolff, A, Konttinen, YT
Přispěvatelé: Lafaurie, Gloria Ines [0000-0003-3986-0625], Strietzel, FP, Lafaurie, GI, Bautista Mendoza, GR, Alajbeg, I, Pejda, S, Vuletic, L, Mantilla, R, Falcao, DP, Leal, SC, BArreto Bezerra, AC, Tran, SD, Menard, HA, Kimoto, S, Pan, S, Martin-Granizo, Maniegas Lozano, L, RA, Zunt, SL, Krushinski, CA, Melilli, D, Campisi, G, Paderni, C, Dolce, S, Yepes, JF, Lindh, L, Koray, M, Mumcu, G, Elad, S, Zeevi, I, Aldape Barrios, BC, Lopez Sanchez, RM, Beiski, BZ, Wolff, A, Konttinen, YT
Rok vydání: 2010
Předmět:
Adult
Male
medicine.medical_specialty
Immunology
Settore MED/50 - Scienze Tecniche Mediche Applicate
Electric Stimulation Therapy
Severity of Illness Index
Xerostomia
law.invention
Randomized controlled trial
Quality of life
stomatognathic system
Rheumatology
Double-Blind Method
law
Settore MED/28 - Malattie Odontostomatologiche
Multicenter trial
Severity of illness
otorhinolaryngologic diseases
Immunology and Allergy
Medicine
Humans
Pharmacology (medical)
Prospective Studies
Oral mucosa
Prospective cohort study
Aged
xerostomia
dry mouth
salivary gland hypofunction
saliva
electrical stimulation
electrostimulation
Sjögren’s syndrome
Intention-to-treat analysis
Toxicity
business.industry
Mouth Mucosa
Middle Aged
Dry mouth
Surgery
Oral cavity
Intention to Treat Analysis
stomatognathic diseases
medicine.anatomical_structure
Sjogren's Syndrome
Treatment Outcome
Anesthesia
Female
medicine.symptom
business
Zdroj: Repositorio U. El Bosque
Universidad El Bosque
instacron:Universidad El Bosque
ISSN: 1529-0131
Popis: 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.
Databáze: OpenAIRE
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