NCT03435328

Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Diabetes type2
• Hyposalivation

Interventions

Type	Name	Description
DEVICE	TENS	* Duration of stimulation: 5 minutes. * Frequency: will be fixed at 50 Hertz. * Pulse duration: 250 µs. * Intensity: optimal intensity of TENS (amplitude will be gradually increased to the maximum intensity that the subject will be comfortable and tolerate it). * Sessions: only one session

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2018-02-19
• Last updated: 2018-02-19

Locations

1 site across 1 country: Egypt