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

NCT03435328 | Unknown

• 1 other identifier: P.T.REC/012/001504
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes type2; Hyposalivation

Keywords

TENS

Outcome Measures

Primary Outcomes (1)

• salivary volume

  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. .

  After only one session of five-minutes TENS

Secondary Outcomes (2)

• salivary flow rate

  After only one session of five-minutes TENS

• Eight-item visual analogue scale xerostomia questionnaire

  After only one session of five-minutes TENS

Study Arms (1)

TENS intervention

EXPERIMENTAL

one group receiving TENS: \- The electrode of TENS unit will be placed vertically, externally on skin overlying the parotid gland, in the preauricular area bilaterally, 1 cm in front of the tragus area.

Device: TENS

Interventions

TENS DEVICE

* 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

TENS intervention

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Giza, Cairo Governorate, 11511, Egypt

RECRUITING

MeSH Terms

Conditions

Xerostomia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Hala MH Ezz-eldeen, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, MD

CONTACT

02 01005154209; ali.mohamed@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: February 19, 2018
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)