Acute Salivary Flow Rate Response to Transcutaneous Electrical Nerve Stimulation Versus Electro-acupuncture

Last updated: December 24, 2019
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Saliva And Salivary Gland Dysfunction

Treatment

N/A

Clinical Study ID

NCT04211324
P.T.REC/012/002523
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Between available therapies for dry mouth is electrostimulation. Using an extra-oral device like TENS - which result in a statistically significant - increases the quantity of whole salivary flow rate production in xerostomia patients. The use of acupuncture as an alternative treatment modality for xerostomia has been documented in the Western medical field since the 1980s. Observational studies have demonstrated that acupuncture treatment may increase salivary flow in healthy volunteers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. 100 healthy adult volunteers from both sexes. 2) Application time of TENS andelectro-acupuncture will be fixed for all volunteers between 9:00 am to 11:00 am.
  1. The volunteers will be advised to have nothing to eat, drink, chew gum, coffee intakeand oral hygiene before the test at least by one hour

Exclusion

Exclusion Criteria:

    1. Volunteers under 18 years of age. 2) Pregnant females. 3) Habits (mouth breathing,smoking, alcohol and drug abuse). 4) Cancer patients (patients onchemotherapy/immunotherapy and history of head and neck radiotherapy).

  1. Cardiac patients (cardiac pacemakers and defibrillators). 6) Patients wearinghearing aids. 7) Chronic inflammatory autoimmune disease such as Sjogren's syndrome (an autoimmune disease that induces exocrine dysfunction and abnormalities), otherrheumatologic diseases (including: rheumatoid arthritis, Systemic lupus erythematosus,scleroderma, mixed connective tissue disease, etc), sarcoidosis, amyloidosis, Crohn'sdisease and ulcerative colitis.

  2. Acute oral inflammatory disorders, gingivostomatitis, tonsillitis and dehydration.

  3. Infectious diseases e.g (HIV/AIDS, HCV and Tuberculosis). 10) Patients undergoingthe use of any drugs. 11) Patients with neurological disorders: stroke, parkinson'sdisease, epilepsy, Bell's palsy, Alzheimer's disease, Patients with cerebrovascularproblems, patients with a history of aneurysm and patients with transient ischaemia.

  4. Salivary gland diseases and disorders: agenesis of the salivary glands,sialoadenitis and sialolithiasis. Patients with Salivary duct ligation, history ofsalivary gland pathology, salivary gland inflammation and parotid gland infection.

  5. Psychogenic diseases and conditions: stress, anxiety, nervousness, depression,schizophrenia and eating disorders ( bulimia).

  6. Endocrine diseases: hyperthyroidism, hypothyroidism, Cushing's syndrome andAddison's disease and systemic diseases like diabetes mellitus.

  7. Others: cystic fibrosis, hypertension, fibromyalgia, chronic fatigue syndrome,burning mouth syndrome, primary biliary cirrhosis, liver transplant candidates, renaldiseases, renal dialysis, anemia and atrophic gastritis.

Study Design

Total Participants: 100
Study Start date:
November 04, 2019
Estimated Completion Date:
March 01, 2020

Study Description

It is possible that an increase of the blood fiux in the salivary glands may be one of the mechanisms behind the positive effect of acupuncture on the metabolism of the salivary glands, which leads to an increase of the salivary fiow.

Transcutaneous electric nerve stimulation (TENS) is a non-pharmacological and well known physical therapy modality which is widely for the acute and chronic pain management.

Electrostimulation using an extraoral device like TENS on parotid gland results in a statistically significant increase in the quantity of whole saliva flow rate production.

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.

Connect with a study center

  • Faculty of physical therapy

    Giza, Dokki
    Egypt

    Active - Recruiting

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