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:

OBJECTIVES: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. STUDY DESIGN: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. CONCLUSION: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

Zadik Y,Zeevi I,Luboshitz-Shon N,Dakwar N,Wolff A,Shapira MY,Or R,Elad S

doi

10.4317/medoral.19429

subject

Has Abstract

pub_date

2014-05-01 00:00:00

pages

e212-9

issue

3

eissn

1698-4447

issn

1698-6946

pii

19429

journal_volume

19

pub_type

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