INTRODUCTION: The present study was undertaken to evaluate the safety and effectiveness of a recently developed electrostimulating device mounted on an individualized intra-oral removable appliance. MATERIALS AND METHODS: The device, containing electrodes, a wetness sensor, an electronic circuit and a power source, was tested on patients with xerostomia in a crossover, randomized, sham-controlled, double-blinded, multicenter study. Electrical stimulation and also sham were delivered during 10 min to the oral mucosa, in the mandibular third molar region. Oral dryness was measured by the sensor. As the primary outcome, sensor dryness and xerostomia symptom changes as a result of device wearing were assessed, and compared between active and sham modes. In addition, side-effects were recorded. RESULTS:Electrostimulation resulted in a significant decrease in sensor dryness, leading to a beneficial effect on patients' subjective condition. No significant side-effects were observed.
RCT Entities:
INTRODUCTION: The present study was undertaken to evaluate the safety and effectiveness of a recently developed electrostimulating device mounted on an individualized intra-oral removable appliance. MATERIALS AND METHODS: The device, containing electrodes, a wetness sensor, an electronic circuit and a power source, was tested on patients with xerostomia in a crossover, randomized, sham-controlled, double-blinded, multicenter study. Electrical stimulation and also sham were delivered during 10 min to the oral mucosa, in the mandibular third molar region. Oral dryness was measured by the sensor. As the primary outcome, sensor dryness and xerostomia symptom changes as a result of device wearing were assessed, and compared between active and sham modes. In addition, side-effects were recorded. RESULTS: Electrostimulation resulted in a significant decrease in sensor dryness, leading to a beneficial effect on patients' subjective condition. No significant side-effects were observed.
Authors: Laura S Sasportas; Drew N Hosford; Maria A Sodini; Dale J Waters; Elizabeth A Zambricki; Joëlle K Barral; Edward E Graves; Todd J Brinton; Paul G Yock; Quynh-Thu Le; Davud Sirjani Journal: Oral Surg Oral Med Oral Pathol Oral Radiol Date: 2013-05-03