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

August 17, 2010 updated by: Universidad Autonoma de Nuevo Leon

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico
        • Recruiting
        • C.D. Especialidad de Periodoncia
        • Contact:
        • Contact:
          • Phone Number: +52 81 83 29 42 50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
self-reported xerostomia
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Nuevo Leon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Estimate)

August 18, 2010

Last Update Submitted That Met QC Criteria

August 17, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234 (Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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