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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01174329
Recruitment Status : Unknown
Verified July 2010 by Universidad Autonoma de Nuevo Leon.
Recruitment status was:  Recruiting
First Posted : August 3, 2010
Last Update Posted : August 18, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation
Study Start Date : August 2010
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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"

Outcome Measures

Primary Outcome Measures :
  1. self-reported xerostomia [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174329

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

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

Responsible Party: Dr Mario Cesar Salinas Carmona, Universidad Autónoma de Nuevo León
ClinicalTrials.gov Identifier: NCT01174329     History of Changes
Other Study ID Numbers: 1234
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: July 2010

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