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Efficacy of Transcutaneous Electrical Nerve Stimulation in Patients With Xerostomia (ETENX)

U

Universidad de Murcia

Status

Completed

Conditions

Xerostomia
Dry Mouth

Treatments

Device: Group experimental

Study type

Interventional

Funder types

Other

Identifiers

NCT06708195
ACTA10/2024/CEI

Details and patient eligibility

About

Saliva is a complex fluid with essential functions in the oral cavity, such as lubricating tissues, protecting against microorganisms, and facilitating processes like chewing, swallowing, and speaking. Xerostomia, defined as the subjective sensation of dry mouth, is commonly associated with reduced salivary flow, which can lead to intraoral and extraoral complications, including dental caries, periodontal disease, infections, and functional difficulties like chewing, speaking, and swallowing.

Current treatments for xerostomia, such as saliva substitutes and lubricants, provide only temporary relief and do not address the underlying cause. Pharmacological agents like pilocarpine have shown effectiveness in stimulating salivary flow; however, their use is limited by adverse side effects such as excessive sweating and gastrointestinal discomfort.

In this context, transcutaneous electrical nerve stimulation (TENS), a physical therapy traditionally used for pain relief, has shown significant potential in the therapeutic stimulation of salivary glands. TENS is a non-invasive approach that works by stimulating the auriculotemporal nerve, which innervates the parotid glands, promoting an increase in salivary flow.

This study highlights the therapeutic value of TENS as an effective and safe solution for patients with xerostomia. The findings indicate that TENS therapy can increase salivary flow, alleviate symptoms of dry mouth, and significantly improve patients' quality of life, all without the risks and adverse effects associated with pharmacological treatments.

Full description

Current treatments for xerostomia, such as saliva substitutes and lubricants, provide only temporary relief and do not address the underlying cause. Pharmacological agents like pilocarpine have shown effectiveness in stimulating salivary flow; however, their use is limited by adverse side effects such as excessive sweating and gastrointestinal discomfort.

In this context, transcutaneous electrical nerve stimulation (TENS), a physical therapy traditionally used for pain relief, has shown significant potential in the therapeutic stimulation of salivary glands. TENS is a non-invasive approach that works by stimulating the auriculotemporal nerve, which innervates the parotid glands, promoting an increase in salivary flow.

This study highlights the therapeutic value of TENS as an effective and safe solution for patients with xerostomia. The findings indicate that TENS therapy can increase salivary flow, alleviate symptoms of dry mouth, and significantly improve patients' quality of life,

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Present continuous symptoms of dry mouth for more than three months. Ability to attend the necessary visits to carry out the research.

Exclusion criteria

Patient subjected to total or partial resection of major salivary glands. Patient with decompensated systemic disease. Patient who has undergone radiotherapy. Patient with motor impairments or issues preventing them from following the operator's instructions.

Patient with vertigo, persistent headaches, hearing problems, neuralgias, and/or facial paralysis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Group I :Experimental
Experimental group
Description:
Patients in this group will receive 15 minutes of extraoral TENS applied to the skin over the bilateral parotid glands. The treatment will consist of 3 sessions per week for 3 weeks. Intervention: Type: Active TENS Frequency: 3 sessions per week Session duration: 15 minutes Application area: Skin over the bilateral parotid glands
Treatment:
Device: Group experimental
Control
Sham Comparator group
Description:
Patients in this group will receive 15 minutes of extraoral TENS applied to the skin over the bilateral parotid glands. However, the device will be inactive ( sham ). This treatment will consist of a single session. Intervention: Type: Inactive TENS Frequency: 1 session Session duration: 15 minutes Application area: Skin over the bilateral parotid glands
Treatment:
Device: Group experimental

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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