Evaluation of an Electro-stimulator for the Treatment of Xerostomia

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

Conditions

• Xerostomia

Interventions

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

Sponsors & Collaborators

• Universidad El Bosque, Bogotá

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University of Zagreb

  collaborator OTHER

• McGill University

  collaborator OTHER

• Istanbul University

  collaborator OTHER

• Hebrew University of Jerusalem

  collaborator OTHER

• Universita degli Studi di Palermo

  collaborator OTHER

• Universidad Nacional Autonoma de Mexico

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• University of Brasilia

  collaborator OTHER

• Hospital San Carlos, Madrid

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• University of Helsinki

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Saliwell Ltd.

  lead INDUSTRY

Principal Investigators

• Andy Wolff, DMD · Saliwell Ltd.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2008-04-30

Completion

2010-04-30

Countries

• Finland

Study Locations