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Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation (SALELECTROSTIM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Universidad Autonoma de Nuevo Leon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier:
NCT01174329
First received: July 28, 2010
Last updated: August 17, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Xerostomia
Polypharmacy
Sjögren's Syndrome
 Device: Automatic neuro-electrostimulation by "Saliwell Crown"
Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad Autonoma de Nuevo Leon:

Primary Outcome Measures:
  • self-reported xerostomia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: August 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient-regulated neuro-electrostimulation by "Saliwell Crown"
Patient regulated (by a remote control) neuro-electrostimulation by "Saliwell Crown"
 Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"
On-demand stimulation of the lingual nerveby "Saliwell Crown"
Active Comparator: Automatic neuro-electrostimulation by "Saliwell Crown"
No remote control used
 Device: Automatic neuro-electrostimulation by "Saliwell Crown"
Continuous stimulation of the lingual nerve by "Saliwell Crown"

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174329

Contacts
Contact: Maria G Chapa Arizpe, Dr. +52 81 8329 4230 maiech@hotmail.com

Locations
Mexico
C.D. Especialidad de Periodoncia Recruiting
Monterrey, Nuevo León, Mexico
Contact: María G Chapa Arizpe, Dr.     +52 81 83 46 62 62     maiech@hotmail.com    
Contact     +52 81 83 29 42 50        
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
  More Information

No publications provided

Responsible Party: Dr Mario Cesar Salinas Carmona, Universidad Autónoma de Nuevo León
ClinicalTrials.gov Identifier: NCT01174329     History of Changes
Other Study ID Numbers: 1234
Study First Received: July 28, 2010
Last Updated: August 17, 2010
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Lacrimal Apparatus Diseases
Xerostomia
Sjogren's Syndrome
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Arthritis, Rheumatoid
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dry Eye Syndromes
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013