Oral, gastrointestinal and dental Digestive System Dry mouth, unspecified
Conditions
Interventions
Electrostimulation, Intra-oral electrostimulating device (salivary pacemaker)
Sponsors
University College London Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years of age 2. Have clinical symptoms of xerostomia (dry mouth) due to primary SS syndrome diagnosed on the basis of 2001 EUUSA classification criteria 3. Degree of dry mouth symptoms: a minimum degree of dryness of 50mm (=50mm) on a 100mm VAS scale (0= no dryness; 100 = maximum dryness) 4. NO systemic sialogogue therapy (e.g. pilocarpine) for the duration of the study 5. Female patients of child bearing potential must have a negative pregnancy test within twenty-four hours of enrolment 6. To understand and consent in writing to the procedure 7. To agree to undergo all the examinations and clinical evaluations of the study 8. To have evidence of residual salivary gland function, by demonstrating an increase in salivary flow on appropriate stimulation e.g. citric acid stimulation or chewing paraffin wax) 9. To have unstimulated whole salivary flow higher than 0 ml/15min (unstimulated salivary flow as measured via sialometry for 15 minutes) 10. Male and female particioants
Exclusion criteria
Exclusion criteria: 1. Severe systemic disease (on the basis of the classification of the American Society of Anesthesiology: ASAIII and ASA IV) 2. Known allergy to materials similar to those used in the investigational product 3. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing aids 4. Complete lower edentulous status (i.e. possess no lower teeth) 5. To have oral anatomical or disease-related characteristics that preclude the insertion of the device (e.g. mandibular torus, severe trismus) 6. To be unable or unwilling to cooperate with study procedures 7. To have evidence of no residual salivary gland function (via citric acid stimulation or chewing paraffin wax test) 8. To have an unstimulated whole salivary flow = 0 ml/15min (Absence of unstimulated salivary flow as measured via sialometry for 15 minutes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in dry mouth symptoms measured at 1, 2, 4, 5 months | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed