- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07593495
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Edith Lara-Carrillo, PhD
- Numéro de téléphone: 132 +527222126464
- E-mail: elarac@uaemex.mx
Sauvegarde des contacts de l'étude
- Nom: Víctor Hugo Toral-Rizo, PhD
- Numéro de téléphone: +525540759303
- E-mail: vhtoralr@uaemex.mx
Lieux d'étude
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State of Mexico
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Toluca, State of Mexico, Mexique, 50130
- Recrutement
- Clinic of Oral Medicine and Pathology "Orocentro", School of Dentistry, Autonomous University of the State of Mexico
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Contact:
- Victor Hugo Toral-Rizo, PhD
- Numéro de téléphone: +527269721268
- E-mail: vhtoralr@uamex.mx
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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.
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Expérimental: magnetic fields
A second therapy involves the application of magnetic fields if neurostimulation does not increase saliva production.
This is applied for 30 minutes.
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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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Salivary flow rate (mL/min)
Délai: one year
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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.
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one year
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Salivary pH
Délai: one year
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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.
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one year
|
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Buffer capacity of saliva
Délai: one year
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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.
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one year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in health-related quality of life
Délai: 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.
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One month
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Edith Lara-Carrillo, PhD, Professor, School of Dentistry, Autonomous University of the State of Mexico
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CEICIEAO-2025-004
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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