Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth

NCT07593495 · tracked via the Priya Life Science Mexico tracker

Sponsor

Universidad Autonoma del Estado de Mexico

Phase

Not applicable

Started

2026-02-01

Last updated

2026-05-18

Condition(s) studied

Saliva Altered

Investigational drug(s) / intervention(s)

electrotherapy and physical therapy device

electrotherapy and physical therapy device: Previous studies have evaluated the impact of TENS on improving salivary hypofunction, mentioning that placing the device on the parotid gland stimulates the postganglionic efferent fibers of the auriculotemporal nerve, improving the secretomotor impulse of the parotid gland.

Study summary

Hyposalivation is a condition that has increased in frequency, primarily due to the degeneration of salivary glands caused by aging, polypharmacy, chronic or autoimmune diseases, or radiation treatments. Most of these factors are associated with the elderly, a growing demographic due to the aging population. Therefore, addressing this condition has become crucial in our population, as has understanding how it affects their quality of life. Given that saliva plays a vital role in maintaining the oral mucosa, tooth structure, initiating digestion, and even speech, a long-term treatment to stimulate salivary production would be extremely helpful in resolving these problems. Currently, only palliative measures that temporarily cover or lubricate the oral cavity and its structures are available.

Among the most innovative treatments is neuroelectrical stimulation (TENS) as an adjunct in the therapy of dry mouth, which has shown improvement; however, this improvement has not been quantified through objective measurements that would allow for determining the quantity and quality of saliva, nor in the long term. Likewise, the patient's quality of life affected by this condition has not been assessed.

Therefore, the objective of this project is to evaluate the effect on salivary quality and quantity after the application of neuroelectrical stimulation as a treatment for patients with dry mouth, as well as their quality of life.

Eligibility

Sex

ALL

Min age

12 Years

Max age

90 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Patients diagnosed with dry mouth symptoms. * Patients who wish to participate in the study. * Patients who allow saliva samples to be collected before, during, and after treatment. * Patients who allow the application of transcutaneous electrical nerve stimulation (TENS). * Patients who do not have any active oral infections. * Patients who attend all sialometry assessments and physiotherapy sessions and complete both quality of life questionnaires (initial and final). Exclusion Criteria: * Patients with any other mucosal alteration. * Patients who do not wish to participate in the study. * Patients who do not allow the collection of saliva samples. * Patients who do not allow the application of transcutaneous electrical nerve stimulation (TENS). * Patients with any infectious process in the oral cavity. * Because the study requires the use of low-frequency pulse currents, participants with pacemakers, defibrillators, hearing aids, or cochlear implants will also be excluded from the study.

Primary outcome measure(s)

Salivary flow rate (mL/min) — one year
Change in salivary flow rate (mL/min), from baseline to after the application of 6 neuro-electro-stimulation therapies or magnetic fields according to the branch of the study. Evaluation after 6 months and up to 1 year.
Salivary pH — one year
Salivary pH will be measured to assess salivary acidity from baseline to after the application of 6 neuro-electro-stimulation therapies or magnetic fields according to the branch of the study. Evaluation after 6 months and up to 1 year.
Buffer capacity of saliva — one year
Change in buffer capacity saliva from baseline to after the application of 6 neuro-electro-stimulation therapies or magnetic fields according to the branch of the study. Evaluation after 6 months and up to 1 year.

Trial sites (1)

Facility	City	Region	Status
Clinic of Oral Medicine and Pathology "Orocentro", School of Dentistry, Autonomous University of the State of Mexico	Toluca	State of Mexico	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07593495 on ClinicalTrials.gov ↗ ← All trials in Mexico