Malic Acid in Treatment of Xerostomia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Malic Acid Spray in Treatment of Xerostomia in Type II Diabetic Patients

Conditions
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Xerostomia

Intervention / Treatment
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* Drug: malic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes mellitus suffering from xerostomia. Patients aged between 35 and 50 years old. Glycated hemoglobin less than 7% (28) . Duration of diabetes mellitus not less than 4 years and not more than 8 years. Exclusion Criteria: Patients receiving any drugs that cause hyposalivation like anti-hypertensive drugs. Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus) (8). Patients receiving chemo-therapy and radio-therapy. Mouth breathers.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: malic acid group<br>patients will receive a topical spray containing 1% malic acid | Drug: malic acid<br>* 1% malic acid spray<br>* Other names: hydroxybutanoic;|
| No Intervention: placebo group<br>patients will receive a topical placebo spray | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |