Diabetes Mellitus, Xerostomia
Conditions
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.
Interventions
OTHERDiode 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
OTHERPlacebo Diode laser
the tip of the instrument will be sealed with blue rubber to prevent the passage of light
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed