Evaluation of an Electro-stimulator for the Treatment of Xerostomia (GenNarino)
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Safety and Performance Evaluation of an Electro-stimulator Mounted on an Intra-oral Removable Appliance (Saliwell GenNarino) for the Treatment of Xerostomia|
- Significant symptomatic improvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 1- Increased salivary output 2- Event free use (no adverse side-effects) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Sham Comparator: electrostimulation
Use of device for predetermined length
Other Name: GenNarino
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.
|Helsinki University Central Hospital and University of Helsinki|
|Helsinki, Finland, 00014|
|Study Director:||Andy Wolff, DMD||Saliwell Ltd.|