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

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.

Study Overview

• Status: Recruiting
• Conditions: Saliva Altered
• Intervention / Treatment: Device: electrotherapy and physical therapy device

Detailed Description

Participants: Patients attending the Orocentro Clinic of the Faculty of Dentistry at the Autonomous University of the State of Mexico with dry mouth symptoms who, upon diagnosis, present with hyposalivation, and who provide their consent and assent to participate in the study.

Sampling: Non-probabilistic, quota and convenience sampling.

Procedure A clinical examination will be performed to identify patients with dry mouth for confirmatory diagnosis and collection of clinical data. If necessary, a biopsy will be taken to identify Sjögren's disease. After obtaining informed consent and assent, baseline salivary samples will be taken for comparison after neuroelectrostimulation treatment. The Xerostomia Quality of Life Questionnaire will also be administered to assess any changes in quality of life following treatment.

To evaluate oral moisture, the time it takes for saliva droplets to form on the inner surface of the buccal mucosa of the lower lip will be measured; this should be less than 60 seconds.

Subsequently, the stimulated saliva will be collected by instructing the patient to chew paraffin gum for 5 minutes and then pour all the saliva produced into a calibrated cup. Saliva samples will be collected between 10 and 11 a.m. on study days to standardize the effect of circadian rhythms on salivary parameter assessment. All participants will be instructed to refrain from chewing gum or candy, eating, drinking any liquids or alcohol, smoking, or brushing their teeth for approximately two hours prior to sample collection.

Salivary pH and buffering capacity will be evaluated using reagent strips (Saliva-Check Buffer (GC, Alsip, IL, USA)) by immersing them in the stimulated saliva sample. The value will be assigned by colorimetric comparison with the manufacturer's chart. Saliva viscosity will be visually determined. Photographic records of the measurements will be taken to clarify any doubts in their interpretation. After determining the salivary values, and if the participant requests and accepts it, neuro-electrostimulation will be applied. This application will be performed using self-adhesive electrodes (Theratrode or Physiotrode). Before placing the electrodes, the skin area corresponding to the parotid and submandibular glands will be cleaned. The electrodes will be placed bilaterally in this area, and the BTL device will be programmed to TENS current mode with parameters of 4 Hz and a wavelength of 250 µs. The intensity will be adjusted until a visible contraction of the facial muscles is achieved and the patient tolerates it.

The Sialometry will be obtained before and after therapy. TENS will be applied twice a week for three weeks. If no changes are seen, the therapy will be changed to magnetic fields.

Participants will be followed up at 6 months, during which maintenance therapy will be carried out, and again 1 year after the application of the first therapy.

Quality of life and identification of oral lesions will be assessed at two time points (before and at the end of the study). This therapy may vary depending on the severity of the case (hyposalivation/Sjögren's syndrome).

Many of these patients require tooth extractions due to dental demineralization and loss of healthy supporting tissues. In these cases, the demineralization of the extracted tooth caused by the lack of mineral content provided by saliva will be evaluated through Vickers microhardness and Diagnodent measurements.

Statistical analysis The results will be subjected to the SPSS statistical package, version 26, obtaining descriptive statistics and checking the normality of the corresponding samples, in order to apply the Student's T test for paired samples, ANOVA of repeated measures and Pearson correlation to relate sociodemographic data, with a p-value≤0.05 to find statistically significant differences.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edith Lara-Carrillo, PhD; Phone Number: 132 +527222126464; Email: elarac@uaemex.mx
• Study Contact Backup: Name: Víctor Hugo Toral-Rizo, PhD; Phone Number: +525540759303; Email: vhtoralr@uaemex.mx

Study Locations

• Mexico
  • State of Mexico
    • Toluca, State of Mexico, Mexico, 50130
      • Recruiting
      • Clinic of Oral Medicine and Pathology "Orocentro", School of Dentistry, Autonomous University of the State of Mexico
      • Contact: Victor Hugo Toral-Rizo, PhD; Phone Number: +527269721268; Email: vhtoralr@uamex.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neuroelectrostimulation; 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; 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.
Experimental: magnetic fields; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health-related quality of life	Change in health-related quality of life measured by the Xerostomia Quality of Life Questionnaire (XeQoLS) from baseline to 4 weeks after physiotherapy treatment.	One month

Collaborators and Investigators

• Sponsor: Universidad Autonoma del Estado de Mexico
• Investigators: Principal Investigator: Edith Lara-Carrillo, PhD, Professor, School of Dentistry, Autonomous University of the State of Mexico

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Xerostomia; Saliva; Physical Therapy Modalities; Salivation
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Xerostomia; Sialorrhea; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy
• Other Study ID Numbers: CEICIEAO-2025-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual data supporting the study results will be shared with qualified researchers upon reasonable request, following publication of the results, through an institutional repository and under a data use agreement.
• IPD Sharing Time Frame: The study results will be shared upon reasonable request, following publication of the results
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No