Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients

November 21, 2024 updated by: Hams Hamed Abdelrahman

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diode laser
Other: Diode Laser 980 nm, 0.2W
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 Comparator: placebo diode laser
Other: Placebo Diode laser
the tip of the instrument will be sealed with blue rubber to prevent the passage of light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
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
baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
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.
baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0404-9/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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