Safety and efficacy of an intra-oral electrostimulator for the relief of dry mouth in patients with chronic graft versus host disease: Case Series

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

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Safety and efficacy of an intra-oral electrostimulator for the relief of dry mouth in patients with chronic graft versus host disease: Case series.

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.

A randomized controlled trial of visible-light therapy for the prevention of oral mucositis.

The objective of this study was to assess the efficacy of a novel visible-light therapy (VLT) device for the prevention of oral mucositis in hematopoietic stem cell transplantation (HSCT) patients. A VLT-device suitable for intra-oral use was applied to 20 patients undergoing HSCT. The study design was placebo-controlled, randomized and double-blind. Oral mucositis was assessed using the OMAS and WHO scales. Oral pain and acceptance levels were scored by the patient using a 10-step scale. Patients were evaluated once a week until day 21 post-HSCT. Mucositis rate, severity and pain score were compared. At the third visit, 1week post-HSCT, mucositis rates were significantly lower in the treatment group (for both WHO and OMAS p=0.02). Mucositis was also less severe in the treatment group (for WHO p=0.01; for OMAS p=0.01). Furthermore, the patients in the treatment group reported lower pain levels (p=0.04). The treatment was well tolerated and highly accepted, with no reports of adverse events related to the device. These findings suggest that the VLT-device is safe and effective for the prevention of oral mucositis in patients undergoing HSCT.