Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究者
Edith Lara-Carrillo
Professor
Universidad Autonoma del Estado de Mexico