Malic Acid in Treatment of Xerostomia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-11-01

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.

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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.

Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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malic acid group

patients will receive a topical spray containing 1% malic acid

Group Type EXPERIMENTAL

malic acid

Intervention Type DRUG

1% malic acid spray

placebo group

patients will receive a topical placebo spray

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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malic acid

1% malic acid spray

Intervention Type DRUG

Other Intervention Names

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hydroxybutanoic

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes