Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients

NCT ID: NCT06703372

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2024-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diode laser

Group Type: EXPERIMENTAL

Diode Laser 980 nm, 0.2W

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo Diode laser

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Placebo Diode laser

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant Lecturer of Dental Public Health and biostatistical consultanat

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0404-9/22

Identifier Type: -

Identifier Source: org_study_id