6533b85afe1ef96bd12b98a0

RESEARCH PRODUCT

Intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial

Meltem KorayRafael Martín-granizoDomenica MatrangaSlavica PejdaClaire LassauzayBen Z. BeiskiLiselott LindhAna Cristina Barreto BezerraL. ManiegasLea VuletićRodrigo M. López SánchezJuan F. YepesYrjö T. KonttinenSuguru KimotoSoraya Coelho LealSharon EladBeatriz Catalina Aldape BarriosGiuseppina CampisiCarlo PaderniIva AlajbegDenise Pinheiro FalcãoItai ZeeviOlivier FromentinDario MelilliGonca MumcuGloria Inés LafaurieSimon D. TranShaoxia PanCheryl A. KrushinskiAndy WolffGloria Rocío Bautista MendozaRubén D. MantillaSusan L. ZuntFrank Peter StrietzelHenri A Ménard

subject

MaleTime FactorsDentistryxerostomia; intraoral saliva electrostimulatorPrimary outcomexerostomia genNarinoMedicineProspective StudiesYoung adultProspective cohort studyLikelihood FunctionsMiddle AgedTreatment OutcomeFemaleOral SurgeryOpen labelAdultSleep Wake DisordersSettore MED/50 - Scienze Tecniche Mediche ApplicateElectric Stimulation TherapyLingual NerveXerostomiaSpeech DisordersXerostomíaNervio lingualPathology and Forensic MedicineSettore MED/01 - Statistica MedicaYoung AdultSwallowingstomatognathic systemSettore MED/28 - Malattie OdontostomatologicheMulticenter trialotorhinolaryngologic diseasesHumansRadiology Nuclear Medicine and imagingDentistry (miscellaneous)SalivaAgedChi-Square Distributionbusiness.industryClinical trialstomatognathic diseasesTherapy Computer-AssistedSurgeryEstimulación eléctrica transcutánea del nerviobusinessDeglutition DisordersSecretory RateChi-squared distributionFollow-Up Studies

description

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.

yearjournalcountryeditionlanguage
2012-01-01
10.1016/j.oooo.2012.01.012https://repositorio.unbosque.edu.co