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

Primary Purpose

Diabetes type2, Hyposalivation

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TENS
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes type2 focused on measuring TENS

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University HospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TENS intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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. .

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 27, 2018
Last Updated
February 9, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03435328
Brief Title
Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients
Official Title
Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes type2, Hyposalivation
Keywords
TENS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TENS intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
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
Primary Outcome Measure Information:
Title
salivary volume
Description
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. .
Time Frame
After only one session of five-minutes TENS
Secondary Outcome Measure Information:
Title
salivary flow rate
Description
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.
Time Frame
After only one session of five-minutes TENS
Title
Eight-item visual analogue scale xerostomia questionnaire
Description
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.
Time Frame
After only one session of five-minutes TENS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail, MD
Phone
02 01005154209
Email
ali.mohamed@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala MH Ezz-eldeen, Professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Hospitals
City
Giza
State/Province
Cairo
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala MH Ezzeldeen, professor
Phone
02 01006626043
Email
hm_2@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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