NCT00509808

Evaluation of an Electro-stimulator for the Treatment of Xerostomia

Safety and Performance Evaluation of an Electro-stimulator Mounted on an Intra-oral Removable Appliance (Saliwell GenNarino) for the Treatment of Xerostomia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Saliwell Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multinational trial, aimed at testing the safety and performance of a electrostimulating device ("GenNarino") to treat dry mouth, over one year. The design is as follows: * Multi-center, double blind, sham (placebo) controlled, about 10 xerostomia patients per center * Patients receive a GenNarino (and its remote control) that is programmed for one month sham and one month active mode (the order of which is randomly assigned), and thereafter 9 months at the active mode (divided in period of 3 months, the order of each is randomly assigned at wearing GenNarino for 1, 5 or 10 minutes at a time). Study hypothesis: Gennarino will lead to significant symptomatic improvement \- At the clinic: monthly examinations at the first 2 months, and then every 3 months, including whole saliva collection and questionnaire; at the first visit impression taking for GenNarino preparation

Detailed description

The clinical trial, titled "Safety and performance evaluation of an electro-stimulator mounted on an intra-oral removable appliance (GenNarino) for the treatment of xerostomia" is a prospective, randomized, double-blind, sham-controlled multi-center trial, followed by an open-label study. Study subjects are patients with xerostomia. The purpose of the trial is to test the safety and efficacy of electrostimulation using the GenNarino device. The primary endpoint is significant symptomatic improvement, and the secondary ones, increased salivary output and event free use (no adverse side-effects). The clinical follow-up consists of periodic clinical examinations. In this clinical trial the use of the device is compared between active vs. sham mode for one month each in a double-blind design (Stage I). Thereafter, at Stage II the xerostomia relieving effect of the active device is assessed in an open label design for additional 6 months. Clinic- and home-based questionnaires and whole saliva collections are performed.

Conditions

• Xerostomia

Interventions

Type	Name	Description
DEVICE	Electrostimulation	1. 1st month GN wearing (activated or sham mode) 2. 2nd month wearing (opposite mode) 3. 3rd - 5th month: activated GN wearing for 1, 5 or 10 minutes 4. 6th - 8th month: activated GN wearing for 1, 5 or 10 minutes 5. 9th - 11th month: activated GN wearing for 1, 5 or 10 minutes

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-04-01
• Completion: 2010-04-01
• First posted: 2007-08-01
• Last updated: 2010-04-06

Locations

1 site across 1 country: Finland