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

Universidad Autonoma de Nuevo Leon

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Polypharmacy; Xerostomia; Sjögren's Syndrome

Treatments: Device: Automatic neuro-electrostimulation by "Saliwell Crown"; Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"

Study type: Interventional

Funder types: Other

Identifiers

NCT01174329

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Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Patient-regulated neuro-electrostimulation by "Saliwell Crown"

Experimental group

Description:

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

Treatment:

Device: Patient-regulated neuro-electrostimulation by "Saliwell Crown"

Automatic neuro-electrostimulation by "Saliwell Crown"

Active Comparator group

Description:

No remote control used

Treatment:

Device: Automatic neuro-electrostimulation by "Saliwell Crown"