Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation

Xerostomia Clinical Trial

— SALELECTROSTIM  

Official title:

Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01174329
• Other study ID #: 1234
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 28, 2010
• Last updated: August 17, 2010
• Start date: August 2010

Study information

• Verified date: July 2010
• Source: Universidad Autonoma de Nuevo Leon
• Contact: Maria G Chapa Arizpe, Dr.
• Phone: +52 81 8329 4230
• Email: maiech[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polypharmacy
• Sjogren's Syndrome
• Sjögren's Syndrome
• Xerostomia

Intervention

Device:
• Automatic neuro-electrostimulation by "Saliwell Crown"
Continuous stimulation of the lingual nerve by "Saliwell Crown"
• Patient-regulated neuro-electrostimulation by "Saliwell Crown"
On-demand stimulation of the lingual nerveby "Saliwell Crown"

Locations

Country	Name	City	State
Mexico	C.D. Especialidad de Periodoncia	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported xerostomia		4 weeks	No