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Completed

NCT Number: NCT06703372

Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients

Xerostomia is a major oral health problem that if not recognized and treated can have a significant effect on a patient's quality of life. It leads to difficulties with speech, swallowing and taste alteration. Pathological causes of xerostomia are divided into local and systemic factors. Local factors include smoking, salivary gland diseases and head and neck radiation therapy. Systemic factors include autoimmune diseases as Sjögren syndrome and hormonal disorders as Diabetes Mellitus. Photobiomodulation (PBM) previously known as Low Level Laser Therapy (LLLT) is the application of red and near infra-red light over injuries or lesions to improve wound and soft tissue healing, reduce inflammation and give relief for both acute and chronic pain. It also has grabbed the attention over the last few years as an effective treatment for xerostomia.

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Key information

Conditions

Xerostomia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with type 2 diabetes mellitus suffering from xerostomia and on oral hypoglycemic drugs.
  • Glycated hemoglobin less than 7%.
  • Duration of diabetes mellitus not less than 4 years and not more than 8 years

Exclusion criteria

  • Patients receiving any drugs that cause hyposalivation.
  • Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus).
  • Patients receiving chemotherapy and radiotherapy.
  • Individuals with skin lesions in the treatment zone to avoid any complications occurring in this area by laser exposure

Treatment and study plan

Diode Laser 980 nm, 0.2W

Other

diode laser will be used at an operating wavelength of 980 nm, with adoption of the due safety measures in all cases. Laser irradiation will be applied bilaterally to the skin over the area of the submandibular and parotid glands. Irradiation will be applied externally to the parotid gland on a continuous basis and likewise to the submandibular gland moving the laser very slowly over the gland zone

Placebo Diode laser

Other

the tip of the instrument will be sealed with blue rubber to prevent the passage of light

Primary outcomes

  1. Change in severity of xerostomia

    Time frame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks

    Summated Xerostomia Inventory-Dutch Version questionnaire (SXI-D) version will be used to assess the severity of xerostomia.

    Questions:

    • My mouth feels dry when eating a meal.
    • My mouth feels dry.
    • I have difficulty in eating dry foods.
    • I have difficulties swallowing certain foods.
    • My lips feel dry

    Scores:

    • Never scoring 1
    • Occasionally scoring 2
    • Ever scoring 3

  2. Change in unstimulated salivary flow rate

    Time frame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks

    Hypo-salivation will be determined if the unstimulated salivary flow rate is 0.1- 0.2 ml/min or less

  3. Change in stimulated salivary flow rate

    Time frame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks

    Whole-mouth SFR measurement will be conducted at every follow-up time point.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Effectiveness Of Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients (A Randomized, Controlled Clinical Trial)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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