Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation

Phase 2

• Conditions: Polypharmacy; Xerostomia; Sjögren's Syndrome
• Interventions: Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"; Device: Automatic neuro-electrostimulation by "Saliwell Crown"

• Registration Number: NCT01174329
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-07-28
• Study Start: 2010-08
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Last Update Submitted: 2010-08-17
• Last Update Posted: 2010-08-18
• Primary Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient-regulated neuro-electrostimulation by "Saliwell Crown"	Patient-regulated neuro-electrostimulation by "Saliwell Crown"	Patient regulated (by a remote control) neuro-electrostimulation by "Saliwell Crown"
Automatic neuro-electrostimulation by "Saliwell Crown"	Automatic neuro-electrostimulation by "Saliwell Crown"	No remote control used

Primary Outcome Measures

Name	Time	Method
self-reported xerostomia	4 weeks

Trial Locations

Locations (1)

C.D. Especialidad de Periodoncia; 🇲🇽 Monterrey, Nuevo León, Mexico