Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- salivary volume
研究概览
简要总结
This study evaluates response of abnormal low salivary flow rate to transcutaneous electrical nerve stimulation (TENS) in diabetic type 2 patients. Response of saliva monitored for all participants receiving only one session of 5-minute extraoral TENS on bilateral parotid glands.
详细描述
Diabetes mellitus is the most significant disorder associated with varied oral manifestation ranging from xerostomia (subjective sensation od dry mouth) to serious bacterial and fungal infections due to alterations in flow rate of saliva.
Systemic agents increase rate of stimulated salivary flow but often have unfavourable side effects such as profuse sweating, rhinitis, dyspepsia.
Use of TENS in stimulation of saliva has been studied in the past which showed moderate promising results. However, it never became a part of the mainstream therapy of hyposalivation.
It has been postulated that transcutaneous electric nerve stimulation (TENS) could directly stimulate the auriculotemporal nerve, which supplies the parotid gland, whereas it remains unclear whether there is also an indirect action (via afferent pathways) onto the salivary reflex arch.
Starting a prevention program as early as possible considering the most practical, cost effective and efficient treatments with the best risk-benefit ratio will help to diminish dry mouth symptoms and sequelae (intraoral and extraoral complications).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-smoker diabetic patients type II
- •Patients with unstimulated resting saliva ≤ 0.16 ml/min considered to be abnormally low flow rate and included in the study (Navazesh et al., 1992)
排除标准
- •Cancer patients (patients on chemotherapy/immunotherapy and history of head and neck radiotherapy).
- •Cardiac patients (cardiac pacemakers and defibrillators).
- •Patients wearing hearing aids.
- •Chronic inflammatory autoimmune diseases
- •Acute oral inflammatory disorders
- •Patients with neurological disorders.
- •Habits (mouth breathing, smoking, alcohol and drug abuse).
- •Salivary gland diseases and disorders.
- •Psychogenic diseases.
- •Endocrine diseases.
- •Patients undergoing pharmacological management for xerostomia.
结局指标
主要结局
salivary volume
时间窗: After only one session of five-minutes TENS
It is estimated as follow: * The patients advised to have nothing to eat, drink, chew gum, intake coffee and oral hygiene before the test. * whole resting salivary volume (ml) planned to be performed using low forced spitting technique in graduated test tube before TENS application. * stimulated salivary volume (ml) collected after TENS application is compared to whole resting salivary volume to assess improvement. .
次要结局
- Eight-item visual analogue scale xerostomia questionnaire(After only one session of five-minutes TENS)
- salivary flow rate(After only one session of five-minutes TENS)
研究者
Ali Mohamed Ali ismail
Principal Investigator
Cairo University