About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Sequential
Treatments tested in this trial
electrotherapy and physical therapy device
DevicePrevious 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
Sponsors and contacts
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