Evaluation of an Electro-stimulator for the Treatment of Xerostomia

NCT00509808 | Completed Phase 4

• 1 other identifier: 1-Wolff
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Significant symptomatic improvement

  1 year

Secondary Outcomes (1)

• 1- Increased salivary output 2- Event free use (no adverse side-effects)

  1 year

Study Arms (1)

electrostimulation

SHAM COMPARATOR

Use of device for predetermined length

Device: Electrostimulation

Interventions

Electrostimulation DEVICE

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

Also known as: GenNarino

electrostimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be at least 18 years of age.
• The patient must have clinical symptoms of xerostomia (dry mouth) due to
• Primary or secondary Sjögren's syndrome
• Medication intake
• Head and neck radiation with survival expectancy of more than one year
• Chronic graft vs. host disease with survival expectancy of more than one year
• Patients are requested not to take systemic sialogogues during the first 2 months of the study (when active is tested vs. sham)
• Female patients of child bearing potential must have a negative pregnancy test within twenty-four hours of enrollment.
• The patient must understand and consent in writing to the procedure.
• The patient agrees to undergo all examinations and clinical evaluations planned for the study.

You may not qualify if:

• Active HIV or HCV infection
• Severe systemic disease
• Known allergy to materials similar to be used in the investigational product
• Known mental disease
• Presence of depression, by positive answers to both the following questions:
• "During the past month have you often been bothered by feeling down, depressed or hopeless?"
• "During the past month have you often been bothered by little interest or pleasure in doing things?"
• Patients wearing other active implants like pacemaker or defibrillator
• Patients with poor oral hygiene
• Patients whose oral anatomical characteristics precludes the insertion of the device
• Patients who are unable or unwilling to cooperate with study procedures.
• Pregnancy
• Presence of erosive or ulcerative oral lesions, which are chronic or recurrent, such as erosive lichen planus, RAS, eryth. Candidosis, and of suspected pre-malignant or malignant lesions

Sponsors & Collaborators

• Saliwell Ltd.: lead
• Universidad El Bosque, Bogotá: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Zagreb: collaborator
• McGill University: collaborator
• Istanbul University: collaborator
• Hebrew University of Jerusalem: collaborator
• Universita degli Studi di Palermo: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator
• Skane University Hospital: collaborator
• University of Brasilia: collaborator
• Hospital San Carlos, Madrid: collaborator
• University of Kentucky: collaborator
• University of Helsinki: collaborator
• Indiana University: collaborator

Study Sites (1)

Helsinki University Central Hospital and University of Helsinki

Helsinki, 00014, Finland

Location

Related Publications (1)

• Strietzel FP, Lafaurie GI, Mendoza GR, Alajbeg I, Pejda S, Vuletic L, Mantilla R, Falcao DP, Leal SC, Bezerra AC, Tran SD, Menard HA, Kimoto S, Pan S, Martin-Granizo RA, Lozano ML, Zunt SL, Krushinski CA, Melilli D, Campisi G, Paderni C, Dolce S, Yepes JF, Lindh L, Koray M, Mumcu G, Elad S, Zeevi I, Barrios BC, Lopez Sanchez RM, Beiski BZ, Wolff A, Konttinen YT. Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial. Arthritis Rheum. 2011 Jan;63(1):180-90. doi: 10.1002/art.27766.

  PMID: 20882668 DERIVED

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andy Wolff, DMD

  Saliwell Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: January 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2010
• Last Updated: April 6, 2010

Record last verified: 2010-04

Locations

FI (1)