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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Universidad Autonoma de Nuevo Leon.
Recruitment status was:  Recruiting
Information provided by:
Universidad Autonoma de Nuevo Leon Identifier:
First received: July 28, 2010
Last updated: August 17, 2010
Last verified: July 2010
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
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

Resource links provided by NLM:

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

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

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"


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01174329

Contact: Maria G Chapa Arizpe, Dr. +52 81 8329 4230

C.D. Especialidad de Periodoncia Recruiting
Monterrey, Nuevo León, Mexico
Contact: María G Chapa Arizpe, Dr.    +52 81 83 46 62 62   
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 Identifier: NCT01174329     History of Changes
Other Study ID Numbers: 1234
Study First Received: July 28, 2010
Last Updated: August 17, 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 processed this record on September 21, 2017