Clinical trial NCT03435328: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes type2
Hyposalivation
Keywords: TENS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: salivary volume
timeFrame: After only one session of five-minutes TENS
Secondary outcomes:
measure: salivary flow rate
timeFrame: After only one session of five-minutes TENS
measure: Eight-item visual analogue scale xerostomia questionnaire
timeFrame: After only one session of five-minutes TENS
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University Hospitals
state: Cairo
Study officials:
affiliation: Cairo University
name: Hala MH Ezz-eldeen, Professor
role: PRINCIPAL_INVESTIGATOR
References: