Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation

NCT ID: NCT01174329

Last Updated: 2010-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Xerostomia Polypharmacy Sjögren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient-regulated neuro-electrostimulation by "Saliwell Crown"

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

Group Type EXPERIMENTAL

Patient-regulated neuro-electrostimulation by "Saliwell Crown"

Intervention Type DEVICE

On-demand stimulation of the lingual nerveby "Saliwell Crown"

Automatic neuro-electrostimulation by "Saliwell Crown"

No remote control used

Group Type ACTIVE_COMPARATOR

Automatic neuro-electrostimulation by "Saliwell Crown"

Intervention Type DEVICE

Continuous stimulation of the lingual nerve by "Saliwell Crown"

Interventions

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Automatic neuro-electrostimulation by "Saliwell Crown"

Continuous stimulation of the lingual nerve by "Saliwell Crown"

Intervention Type DEVICE

Patient-regulated neuro-electrostimulation by "Saliwell Crown"

On-demand stimulation of the lingual nerveby "Saliwell Crown"

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role lead

Responsible Party

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Universidad Autónoma de Nuevo León

Locations

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C.D. Especialidad de Periodoncia

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Maria G Chapa Arizpe, Dr.

Role: CONTACT

+52 81 8329 4230

Facility Contacts

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María G Chapa Arizpe, Dr.

Role: primary

+52 81 83 46 62 62

Role: backup

+52 81 83 29 42 50

Other Identifiers

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1234

Identifier Type: -

Identifier Source: org_study_id

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