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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diode laser | Experimental |
| |
| placebo diode laser | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of xerostomia | Summated Xerostomia Inventory-Dutch Version questionnaire (SXI-D) version will be used to assess the severity of xerostomia. Questions:
Scores:
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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|
| Placebo Diode laser | Other | the tip of the instrument will be sealed with blue rubber to prevent the passage of light |
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |