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

13 maja 2026 zaktualizowane przez: Edith Lara-Carrillo, Universidad Autonoma del Estado de Mexico

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.

Przegląd badań

Status

Rekrutacyjny

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

35

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Edith Lara-Carrillo, PhD
  • Numer telefonu: 132 +527222126464
  • E-mail: elarac@uaemex.mx

Kopia zapasowa kontaktu do badania

  • Nazwa: Víctor Hugo Toral-Rizo, PhD
  • Numer telefonu: +525540759303
  • E-mail: vhtoralr@uaemex.mx

Lokalizacje studiów

    • State of Mexico
      • Toluca, State of Mexico, Meksyk, 50130
        • Rekrutacyjny
        • Clinic of Oral Medicine and Pathology "Orocentro", School of Dentistry, Autonomous University of the State of Mexico
        • Kontakt:
          • Victor Hugo Toral-Rizo, PhD
          • Numer telefonu: +527269721268
          • E-mail: vhtoralr@uamex.mx

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
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.
Eksperymentalny: magnetic fields
A second therapy involves the application of magnetic fields if neurostimulation does not increase saliva production. This is applied for 30 minutes.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Salivary flow rate (mL/min)
Ramy czasowe: 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.
one year
Salivary pH
Ramy czasowe: 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.
one year
Buffer capacity of saliva
Ramy czasowe: 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.
one year

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in health-related quality of life
Ramy czasowe: One month
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Edith Lara-Carrillo, PhD, Professor, School of Dentistry, Autonomous University of the State of Mexico

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 lutego 2026

Zakończenie podstawowe (Szacowany)

31 lipca 2026

Ukończenie studiów (Szacowany)

31 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

2 lutego 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

18 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

The study results will be shared upon reasonable request, following publication of the results

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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