Malic Acid in Treatment of Xerostomia

Phase

N/A

Condition

Saliva And Salivary Gland Dysfunction

Dry Mouth

Treatment

N/A

Clinical Study ID

NCT04756986

Malic acid in xerostomia

Ages 35-50
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Patients receiving any drugs that cause hyposalivation like anti-hypertensive drugs.
Patients with any systemic disease reported to produce hyposalivation (sjogren'ssyndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus) (8).
Patients receiving chemo-therapy and radio-therapy.
Mouth breathers.

Study Design

January 01, 2021

November 01, 2021

Study 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.

Connect with a study center

Faculty of Dentistry, Alexandria University
Alexandria,
Egypt
Active - Recruiting

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