AzTrials
AzTrials

Saliva AlteredNCT07593495

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

A study testing electrotherapy and physical therapy device in people with Saliva Altered, run by Universidad Autonoma del Estado de Mexico at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Saliva Altered
What is being tested?
electrotherapy and physical therapy device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteMexico
Study dates
1 Feb 2026to 31 Jul 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Edith Lara-Carrillo, PhD contact

+527222126464 ext. 132

elarac@uaemex.mx

Víctor Hugo Toral-Rizo, PhD contact

+525540759303

vhtoralr@uaemex.mx

Mexico1 site, 1 recruiting
  • Clinic of Oral Medicine and Pathology "Orocentro", School of Dentistry, Autonomous University of the State of Mexico

    Toluca, State of Mexico, 50130

    Victor Hugo Toral-Rizo, PhD, +527269721268, vhtoralr@uamex.mx

    Recruiting

Other trials in Mexico

About this study

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.

Conditions
Saliva Altered
Being tested
electrotherapy and physical therapy device
Keywords
Saliva, Salivation, Xerostomia, Quality of life, Physical Therapy Modalities
Medical subject headings
Sialorrhea, Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electrotherapy and physical therapy deviceDevice

    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 groups in NCT07593495
Study groupRoleWhat they receive
neuroelectrostimulationExperimentalNeuro-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.
Receives: Device: electrotherapy and physical therapy device
magnetic fieldsExperimentalA second therapy involves the application of magnetic fields if neurostimulation does not increase saliva production. This is applied for 30 minutes.
Receives: Device: electrotherapy and physical therapy device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: one year

Secondary outcomes (1)
  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.

    Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start1 Feb 2026
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07593495
Sponsor's protocol ID
CEICIEAO-2025-004
Status last verified
May 2026
First submitted
2 Feb 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in