Polypharmacy, Sjögren's Syndrome, Xerostomia
Conditions
Brief summary
The objective of the study is to evaluate with clinical parameters the performance of Saliwell Crown as a neuro-electrostimulator of the submandibular and sublingual salivary glands in hypofunction status due to polypharmacy or Sjögren's Syndrome in patients with symptoms of xerostomia.
Interventions
DEVICEAutomatic neuro-electrostimulation by Saliwell Crown
Continuous stimulation of the lingual nerve by Saliwell Crown
DEVICEPatient-regulated neuro-electrostimulation by Saliwell Crown
On-demand stimulation of the lingual nerveby Saliwell Crown
Sponsors
Universidad Autonoma de Nuevo Leon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age range between 18 and 75 years of age * Clinical symptoms of xerostomia * Difference in whole salivary flow between resting and stimulating conditions * Patient ASA type I to III * Absence of at least one mandibular third molar inferior, but at least partially dentated in the mandible
Exclusion criteria
* Patients with antimicrobial treatments in the three previous months * Smokers * Intake of bisphosphonates * Limitation of mandibular opening * Interoclusal distance smaller than 10 millimetres * Lack of adequate bone availability for implant placement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| self-reported xerostomia | 4 weeks |
Countries
Mexico
Contacts
Primary ContactMaria G Chapa Arizpe, Dr.
Outcome results
None listed