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

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Hyposalivation
Diabetes type2

Treatments

Device: TENS

Study type

Interventional

Funder types

Other

Identifiers

NCT03435328
P.T.REC/012/001504

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

TENS intervention
Experimental group
Description:
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.
Treatment:
Device: TENS

Trial contacts and locations

1

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Central trial contact

Ali MA Ismail, MD

Data sourced from clinicaltrials.gov

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