Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients

NCT06703372 | Completed

• 1 other identifier: 0404-9/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Xerostomia; Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change in severity of xerostomia

  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

  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

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

  baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks

Study Arms (2)

Diode laser

EXPERIMENTAL

Other: Diode Laser 980 nm, 0.2W

placebo diode laser

PLACEBO COMPARATOR

Other: Placebo Diode laser

Interventions

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

Diode laser

Placebo Diode laser OTHER

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

placebo diode laser

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Egypt

Location

MeSH Terms

Conditions

Xerostomia; Diabetes Mellitus

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: October 20, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

EG (1)