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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes type2; Hyposalivation
• Intervention / Treatment: Device: TENS

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Giza, Cairo, Egypt, 11511
      • Recruiting
      • Cairo University Hospitals
      • Contact: Hala MH Ezzeldeen, professor; Phone Number: 02 01006626043; Email: hm_2@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. non-smoker diabetic patients type II
2. 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TENS intervention; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary flow rate	It is estimated as follow: By dividing whole resting salivary volume on five minute collection period , thus whole resting salivary flow rate (ml/minute) is obtained.; Dividing stimulated salivary volume - collected after TENS application - on five minute collection period, thus stimulated salivary flow rate (ml/minute) is obtained.; Assessing improvement is done by comparing stimulated with whole resting salivary flow rate.	After only one session of five-minutes TENS
Eight-item visual analogue scale xerostomia questionnaire	Visual analogue scale is a horizontal line,100 millimeters (mm) in length and anchored by word descriptors at each end.; Items are "Rate the difficulty you experience in swallowing due to dryness", "Rate the difficulty you experience in speaking due to dryness","Rate how much saliva is in your mouth","Rate the dryness of your mouth", "Rate the dryness of your throat", "Rate the dryness of your lips", "Rate the dryness of your tongue" ," Rate the level of your thirst" respectively.; Before and after treatment, the researcher ask each item to the patient.Then, the patient ts asked to mark his response (perception of his current state) for the item by placing a vertical line on the scale of each item.; The researcher determine scale score response of each item by measuring distance in mm.; Decreased post-treatment of visual analogue scale score for each item considered improvement.	After only one session of five-minutes TENS

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hala MH Ezz-eldeen, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): May 1, 2018
• Study Completion (ANTICIPATED): May 1, 2018

Study Registration Dates

• First Submitted: January 27, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: TENS
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Diabetes Mellitus, Type 2; Xerostomia
• Other Study ID Numbers: P.T.REC/012/001504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO