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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

July 28, 2010
August 17, 2010
August 2010
December 2010   (final data collection date for primary outcome measure)
self-reported xerostomia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01174329 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation
Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Xerostomia
  • Polypharmacy
  • Sjögren's Syndrome
  • Device: Automatic neuro-electrostimulation by "Saliwell Crown"
    Continuous stimulation of the lingual nerve by "Saliwell Crown"
  • Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"
    On-demand stimulation of the lingual nerveby "Saliwell Crown"
  • Experimental: Patient-regulated neuro-electrostimulation by "Saliwell Crown"
    Patient regulated (by a remote control) neuro-electrostimulation by "Saliwell Crown"
    Intervention: Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"
  • Active Comparator: Automatic neuro-electrostimulation by "Saliwell Crown"
    No remote control used
    Intervention: Device: Automatic neuro-electrostimulation by "Saliwell Crown"
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14
Not Provided
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Maria G Chapa Arizpe, Dr. +52 81 8329 4230 maiech@hotmail.com
Mexico
 
NCT01174329
1234
No
Dr Mario Cesar Salinas Carmona, Universidad Autónoma de Nuevo León
Universidad Autonoma de Nuevo Leon
Not Provided
Not Provided
Universidad Autonoma de Nuevo Leon
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP