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Background: xerostomia is a subjective sensation of dry mouth resulting from quantitative and /or qualitative changes of saliva. Patients receiving drugs like antihypertensives and antidepressants or patients receiving chemotherapy or radiotherapy for treatment of head and neck cancers may suffer from xerostomia. It also can be experienced in patients with systemic diseases like diabetes mellitus, systemic lupus erythematosus, sjogren's syndrome and rheumatoid arthritis. Malic acid spray with concentration of 1% has grabbed the attention over the last few years as an effective treatment for xerostomia.
Study objective: To evaluate the effect of 1% malic acid spray in treatment of xerostomia in type 2 diabetic patients.
This randomized controlled clinical trial included 52 patients with type 2 diabetes mellitus suffering from xerostomia, divided equally into two groups. Group-I was managed by topical spray containing 1% malic. Group- II was managed by a placebo spray. Both groups received the treatment for 2 weeks. Dry mouth questionnaire scores (DMQ) and unstimulated salivary flow rate was collected before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| malic acid group | Experimental | patients will receive a topical spray containing 1% malic acid |
|
| placebo group | No Intervention | patients will receive a topical placebo spray |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| malic acid | Drug | 1% malic acid spray |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The unstimulated salivary flow rate | The unstimulated salivary flow rate will be obtained by the spit method every 30s for 15 minutes. Saliva will be collected in graduated tubes. Measurements will be expressed as milliliter per minute. Participants will be asked to refrain from eating, drinking and brushing their teeth at least 2 hours before saliva collection - Hypo-salivation if the unstimulated salivary flow rate 0.1- 0.2 ml/min or less | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| scoring of severity of xerostomia | Each individual's responses will be scored and summed to give a single score and the higher scores represent more severe symptoms using Xerostomia Inventory-Dutch version | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eglal M Mousa, PHD | Alexandria University | Study Director |
| Yasmin Y Gaweesh., PHD | Alexandria University | Principal Investigator |
| Noha K. Abo Aasy, PHD | Alexandria University | Principal Investigator |
| Shaimaa A. Muhamed, BDS | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Recruiting | Alexandria | Egypt |
The investigators are planning to share the methods and the results of this study with all the investigators
starting 6 months after publication
he sharing access can be through PubMed when the study is published or through direct contact through this email
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C030298 | malic acid |
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