Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435328
Recruitment Status : Unknown
Verified February 2018 by Ali Mohamed Ali ismail, Cairo University.
Recruitment status was:  Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ali Mohamed Ali ismail, Cairo University

Tracking Information
First Submitted Date  ICMJE January 27, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date February 19, 2018
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
salivary volume [ Time Frame: After only one session of five-minutes TENS ]
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. .
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • salivary flow rate [ Time Frame: After only one session of five-minutes TENS ]
    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 [ Time Frame: After only one session of five-minutes TENS ]
    • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients
Official Title  ICMJE Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes type2
  • Hyposalivation
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Device: TENS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03435328
Other Study ID Numbers  ICMJE P.T.REC/012/001504
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ali Mohamed Ali ismail, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hala MH Ezz-eldeen, Professor Cairo University
PRS Account Cairo University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP