Malic Acid in Treatment of Xerostomia

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04756986
• Other study ID #: Malic acid in xerostomia
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: February 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Xerostomia

Intervention

Drug:
• malic acid
1% malic acid spray

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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