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Salivary Flow Rate Response to Electrostimulation in HD Patients

Hyposalivation Response to TENS in HD Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04562519
Enrollment
80
Registered
2020-09-24
Start date
2017-01-31
Completion date
2021-05-31
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Complication

Brief summary

Xerostomia is a subjective complaint of dry mouth, whereas hyposalivation is an objective decreased of salivary flow. Hyposalivation was reported in 28.8 % of haemodialysis (HD) patients (Bruzda-Zwiech, 2014).

Detailed description

Stimulation of the salivary glands can be induced mechanically (for example, by chewing gum or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers) or by electrostimulation as transcutnaeous electrical nerve stimulation (TENS) (Bossola and Tazza, 2012). Eighty HD patients (40 diabetics and 40 nondiabetics) will receive 20 minutes of TENS on skin over bilateral parotid gland, 3 times weekly for 3 weeks to investigate the hyposalivation response of diabetic and non diabetic HD patients to TENS.

Interventions

DEVICETENS

Patients of this group will receive 20 minutes of extra oral TENS over skin of bilateral parotid glands (3 sessions weekly for 3 weeks)

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Eighty HD patients (40 diabetics and 40 non diabetics) * HD at least from three month * saliva flow less than or equal 0.15 millilitre per minute

Exclusion criteria

* pulmonary or cardiac disorders * drugs to treat hyposalivation * salivary glands inflammation, tumor, and autoimmune diseases. * smokers and alcholics

Design outcomes

Primary

MeasureTime frameDescription
3-week response of salivary flow rateimmediately after the last sessionthe patients will be ordered to spit saliva in a graduated test tube for 5 minutes after the last session (session number 9). To calculate salivary flow rate: saliva volume will be divided on duration of saliva spitting.

Secondary

MeasureTime frameDescription
immediate response of saliva flowimmediately after the first sessionthe patients will be ordered to spit saliva in a graduated test tube for 5 minutes immediately after the first session . To calculate salivary flow rate: saliva volume will be divided on duration of saliva spitting.

Countries

Egypt

Contacts

Primary ContactAli Ismail, lecturer
allooka2012@gmail.com02 01005154209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026