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

NCT07593495 | Recruiting DMC

• 1 other identifier: CEICIEAO-2025-004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Saliva Altered

Keywords

Saliva; Salivation; Xerostomia; Quality of life; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (3)

• Salivary flow rate (mL/min)

  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.

  one year

• Salivary pH

  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.

  one year

• Buffer capacity of saliva

  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.

  one year

Secondary Outcomes (1)

• Change in health-related quality of life

  One month

Study Arms (2)

neuroelectrostimulation

EXPERIMENTAL

Neuro-electrostimulation will be applied, this application will be carried out with self-adhesive electrodes (Theratrode or Physiotrode) for 30 minutes with the parameters of 4Hz and wavelength of 250µs and the intensity will be adjusted until there is a visible contraction of the facial muscles and the patient's tolerance.

Device: electrotherapy and physical therapy device

magnetic fields

EXPERIMENTAL

A second therapy involves the application of magnetic fields if neurostimulation does not increase saliva production. This is applied for 30 minutes.

Device: electrotherapy and physical therapy device

Interventions

electrotherapy and physical therapy device 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.

magnetic fields; neuroelectrostimulation

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma del Estado de Mexico: lead

Study Sites (1)

Clinic of Oral Medicine and Pathology "Orocentro", School of Dentistry, Autonomous University of the State of Mexico

Toluca, State of Mexico, 50130, Mexico

RECRUITING

MeSH Terms

Conditions

Sialorrhea; Xerostomia

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Edith Lara-Carrillo, PhD

  Professor, School of Dentistry, Autonomous University of the State of Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edith Lara-Carrillo, PhD

CONTACT

+527222126464; elarac@uaemex.mx

Víctor Hugo Toral-Rizo, PhD

CONTACT

+525540759303; vhtoralr@uaemex.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Salivary values will be determined, and subsequently, neuro-electrostimulation will be performed with self-adhering electrodes at the level of the bilateral parotid and submandibular glands; the BTL equipment will be programmed in TENS current type and the parameters of 4Hz and 250µs wave width will be set and the intensity will be adjusted until there is a visible contraction of the facial muscles and the patient's tolerance. The number of therapies will be modified as the study progresses and the patient's response to the therapy evolves, starting with 6 therapies, applying 2 per week. If there is no good response, magnetic fields will be applied to the patient as a second treatment option.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: May 18, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The study results will be shared upon reasonable request, following publication of the results
• Access Criteria: Access to anonymized individual data will be available to qualified researchers who submit a methodologically sound scientific proposal, approved by the research team. Access will be subject to the signing of a data usage agreement.

Locations

ME (1)