Xerostomia
Conditions
Brief summary
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
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.
Interventions
DRUGmalic acid
1% malic acid spray
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The unstimulated salivary flow rate | 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| scoring of severity of xerostomia | 4 weeks | 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 |
Countries
Egypt
Outcome results
None listed