Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients

Not Applicable

Completed

• Conditions: Xerostomia; Diabetes Mellitus

• Registration Number: NCT06703372
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in severity of xerostomia	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
Change in unstimulated salivary flow rate	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
Change in stimulated salivary flow rate	baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks	Whole-mouth SFR measurement will be conducted at every follow-up time point.

Trial Locations

Locations (1)

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