title: Safety and efficacy of an intra-oral electrostimulator for the relief of dry mouth in patients with chronic graft versus host disease: Case series.
abstract: OBJECTIVE
  Patients with chronic graft-versus-host disease (cGVHD) often suffer from dry mouth and oral mucosal lesions. The primary objective of this study was to investigate the safety of an intra-oral electrostimulator (GenNarino) in symptomatic cGVHD patients. The secondary objective was to study the impact on the salivary gland involvement of cGVHD patients.
  
  
  METHODS
  This paper presents a case series. The study included patients treated for 4 weeks, randomly assigned to the active device and then crossed-over to a sham-device or vice versa. The patients and clinicians were blind to the treatment delivered. Data regarding oral mucosal and salivary gland involvement were collected.
  
  
  RESULTS
  Six patients were included in this series. Most of the intraoral areas with manifestations of cGVHD were not in contact with the GenNarino device. Two patients developed mild mucosal lesions in areas in contact with the GenNarino during the study. However, only one of them had a change in the National Institutes of Health (NIH) score for oral cGVHD. The unstimulated and stimulated salivary flow rate increased in 4 out of the 5 patients included in this analysis. Symptoms of dry mouth and general oral comfort improved.
  
  
  CONCLUSIONS
  This study suggests that GenNarino is safe in cGVHD patients with respect to oral tissues. Furthermore the use of GenNarino resulted in subjective and objective improvements in dry mouth symptoms. A large scale study is needed to confirm the impact and safety of GenNarino on systemic cGVHD.
authors.affiliation: Division of Oral Medicine, Eastman Institute of Oral Health, University of Rochester Medical Center, Rochester, NY 14620, selad@urmc.rochester.edu.
authors.forename: Yehuda
authors.initials: Y
authors.lastname: Zadik
authors.forename: Itai
authors.initials: I
authors.lastname: Zeevi
authors.forename: Noa
authors.initials: N
authors.lastname: Luboshitz-Shon
authors.forename: Nasri
authors.initials: N
authors.lastname: Dakwar
authors.forename: Andy
authors.initials: A
authors.lastname: Wolff
authors.forename: Michael Y
authors.initials: MY
authors.lastname: Shapira
authors.forename: Reuven
authors.initials: R
authors.lastname: Or
authors.forename: Sharon
authors.initials: S
authors.lastname: Elad
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D004867:Equipment Design; D005260:Female; D006086:Graft vs Host Disease / Q000150:complications*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012469:Salivary Glands; D016896:Treatment Outcome; D014987:Xerostomia / Q000209:etiology* / Q000628:therapy*