SALELECTROSTIM: Treatment of Salivary Gland Hypofunction With Neuro- Electrostimulation

Sponsor

Universidad Autonoma de Nuevo Leon (Other)

Overall Status

Unknown status

CT.gov ID

NCT01174329

Collaborator

(none)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

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

Study Start Date :

Aug 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2010

Arms and Interventions

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"

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"

Outcome Measures

Primary Outcome Measures

self-reported xerostomia [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	C.D. Especialidad de Periodoncia	Monterrey	Nuevo León	Mexico

Sponsors and Collaborators

Universidad Autonoma de Nuevo Leon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01174329

Other Study ID Numbers:

1234

First Posted:

Aug 3, 2010

Last Update Posted:

Aug 18, 2010

Last Verified:

Jul 1, 2010

Additional relevant MeSH terms:

Sjogren's Syndrome

Xerostomia

Study Results

No Results Posted as of Aug 18, 2010