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RecruitingNCT07593495Updated May 18, 2026

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

An interventional study of electrotherapy and physical therapy device in Saliva Altered, sponsored by Universidad Autonoma del Estado de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 12 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Universidad Autonoma del Estado de Mexico · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
12 Years to 90 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Saliva Altered

Keywords

  • Saliva
  • Salivation
  • Xerostomia
  • Quality of life
  • Physical Therapy Modalities
03

In context

Sialorrhea

60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.

This study's planned enrollment of 35 is above the median of 31 across 44 interventional studies indexed under Sialorrhea.

Browse Sialorrhea studies →

Lead sponsor

Universidad Autonoma del Estado de Mexico is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Deviceelectrotherapy 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one year

  2. 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.

    Time frame: one year

  3. 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.

    Time frame: one year

Secondary outcomes

  1. 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.

    Time frame: One month

07

Study locations

1 of 1 sites recruiting
  • Clinic of Oral Medicine and Pathology "Orocentro", School of Dentistry, Autonomous University of the State of Mexico
    Toluca, State of Mexico 50130, Mexico
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Jul 2026, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2026
First posted
May 18, 2026
StartActual
Feb 1, 2026
Primary completionEst.
Jul 31, 2026
CompletionEst.
Jul 31, 2027
Last update
May 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07593495
Lead sponsor
Universidad Autonoma del Estado de Mexico
Responsible party
Edith Lara-Carrillo (Professor, Universidad Autonoma del Estado de Mexico) — Principal investigator
First posted
May 18, 2026
Start date
Feb 1, 2026
Primary completion
Jul 31, 2026 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
May 18, 2026

Study contacts

Edith Lara-Carrillo, PhD
Contact
elarac@uaemex.mx
+527222126464 ext. 132
Víctor Hugo Toral-Rizo, PhD
Contact
vhtoralr@uaemex.mx
+525540759303
Edith Lara-Carrillo, PhD
principal investigator · Professor, School of Dentistry, Autonomous University of the State of Mexico

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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