Diabetes type2NCT03435328
Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients
A study testing TENS in people with Diabetes type2 and Hyposalivation, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Diabetes type2, Hyposalivation
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- Habits (mouth breathing, smoking, alcohol and drug abuse).
- Salivary gland diseases and disorders.
- Psychogenic diseases.
- Endocrine diseases.
- Patients undergoing pharmacological management for xerostomia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Giza, Cairo Governorate, 11511
Hala MH Ezzeldeen, professor, 02 01006626043, hm_2@yahoo.com
About this study
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).
- Conditions
- Diabetes type2, Hyposalivation
- Being tested
- TENS
- Keywords
- TENS
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. .
Measured: After only one session of five-minutes TENS
Secondary outcomes (2)
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.
Measured: 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.
Measured: After only one session of five-minutes TENS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study startJan 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type2Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Hala MH Ezz-eldeen, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435328
- Sponsor's protocol ID
- P.T.REC/012/001504
- Status last verified
- Feb 2018
- First submitted
- 27 Jan 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients
- ClinicalTrials.gov ID
- NCT03435328
- Acronym / sponsor ID
- P.T.REC/012/001504
- Conditions
- Diabetes type2, Hyposalivation
- Keywords
- TENS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TENS intervention | Experimental | Device: TENSone 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | TENS intervention |
Primary outcome
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. .
2 secondary outcomes
salivary flow rate
Time frame: After only one session of five-minutes TENS
Eight-item visual analogue scale xerostomia questionnaire
Time frame: After only one session of five-minutes TENS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala MH Ezz-eldeen, Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Diabetes type2 and Hyposalivation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, MD (02 01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary volume (time frame: After only one session of five-minutes TENS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.