Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients
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|ClinicalTrials.gov Identifier: NCT03435328|
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes type2 Hyposalivation||Device: TENS||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
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.
- 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. .
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435328
|Contact: Ali MA Ismail, MD||02 email@example.com|
|Cairo University Hospitals||Recruiting|
|Giza, Cairo, Egypt, 11511|
|Contact: Hala MH Ezzeldeen, professor 02 01006626043 firstname.lastname@example.org|
|Principal Investigator:||Hala MH Ezz-eldeen, Professor||Cairo University|