ClinicalTrials.gg
Status unknownNCT03435328Updated Feb 19, 2018

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

An interventional study of TENS in Diabetes type2 and Hyposalivation, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
50 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Xerostomia with a site in Egypt — 3 open to participants now, 5 under way, 1 of them phase 3. Xerostomia · Egypt.

Planned enrollment
Largest of 16
100 · median 44
Started
2017
the only one that year
No phase
12 of 19
3 open now
Registered
2nd of 19
by date
Lead sponsor
2 of 19
Cairo University

Among the 19 studies in Xerostomia with a site in Egypt, this one has the largest planned enrollment of the 16 interventional ones that give a count, is the only one that started in 2017, is one of 12 with no phase, and was the 2nd registered.

Xerostomia

286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.

Browse Xerostomia studies →

Open to participants now

3 of the 19 studies in Xerostomia with a site in Egypt are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 26 Xerostomia studies recruiting now, 15 (58%) set no upper age limit and 7 (27%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.

This study: 50 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

Read the 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).

03

Conditions studied

  • Diabetes type2
  • Hyposalivation

Browse trials for

Keywords

  • TENS
04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceTENS

    * 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

06

What researchers measure

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. .

    Time frame: After only one session of five-minutes TENS

Secondary outcomes

  1. 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.

    Time frame: After only one session of five-minutes TENS

  2. 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.

    Time frame: After only one session of five-minutes TENS

07

Study locations

1 of 1 sites recruiting
  • Cairo University Hospitals
    Giza, Cairo 11511, Egypt
    Recruiting
    • Hala MH Ezzeldeen, professor · Contacthm_2@yahoo.com · 02 01006626043
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2017 (actual). Primary completion is estimated for May 2018, 16 months after the start.

Of 85 non-industry interventional studies with no phase under Xerostomia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's planned 16 months is close to that.

Counting every sponsor, half of 101 studies reached it within 13 months; a quarter within 4 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2018
First posted
Feb 19, 2018
StartActual
Jan 2017
Primary completionEst.
May 2018
CompletionEst.
May 2018
Last update
Feb 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03435328
Lead sponsor
Cairo University
Responsible party
Ali Mohamed Ali ismail (Principal Investigator, Cairo University) — Principal investigator
First posted
Feb 19, 2018
Start date
Jan 2017
Primary completion
May 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Feb 19, 2018

Study contacts

Ali MA Ismail, MD
Contact
ali.mohamed@pt.cu.edu.eg
02 01005154209
Hala MH Ezz-eldeen, Professor
principal investigator · Cairo University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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