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

Primary Purpose

Xerostomia, Polypharmacy, Sjögren's Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Automatic neuro-electrostimulation by "Saliwell Crown"
Patient-regulated neuro-electrostimulation by "Saliwell Crown"
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • C.D. Especialidad de PeriodonciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient-regulated neuro-electrostimulation by "Saliwell Crown"

Automatic neuro-electrostimulation by "Saliwell Crown"

Arm Description

Patient regulated (by a remote control) neuro-electrostimulation by "Saliwell Crown"

No remote control used

Outcomes

Primary Outcome Measures

self-reported xerostomia

Secondary Outcome Measures

Full Information

First Posted
July 28, 2010
Last Updated
August 17, 2010
Sponsor
Universidad Autonoma de Nuevo Leon
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1. Study Identification

Unique Protocol Identification Number
NCT01174329
Brief Title
Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation
Acronym
SALELECTROSTIM
Official Title
Difference in Salivary Flow in Patients With Salivary Gland Hypofunction of the Following Application of Neuro-electrostimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Autonoma de Nuevo Leon

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Polypharmacy, Sjögren's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient-regulated neuro-electrostimulation by "Saliwell Crown"
Arm Type
Experimental
Arm Description
Patient regulated (by a remote control) neuro-electrostimulation by "Saliwell Crown"
Arm Title
Automatic neuro-electrostimulation by "Saliwell Crown"
Arm Type
Active Comparator
Arm Description
No remote control used
Intervention Type
Device
Intervention Name(s)
Automatic neuro-electrostimulation by "Saliwell Crown"
Intervention Description
Continuous stimulation of the lingual nerve by "Saliwell Crown"
Intervention Type
Device
Intervention Name(s)
Patient-regulated neuro-electrostimulation by "Saliwell Crown"
Intervention Description
On-demand stimulation of the lingual nerveby "Saliwell Crown"
Primary Outcome Measure Information:
Title
self-reported xerostomia
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria G Chapa Arizpe, Dr.
Phone
+52 81 8329 4230
Email
maiech@hotmail.com
Facility Information:
Facility Name
C.D. Especialidad de Periodoncia
City
Monterrey
State/Province
Nuevo León
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María G Chapa Arizpe, Dr.
Phone
+52 81 83 46 62 62
Email
maiech@hotmail.com
Phone
+52 81 83 29 42 50

12. IPD Sharing Statement

Learn more about this trial

Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation

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