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Malic Acid in Treatment of Xerostomia

H

Hams Hamed Abdelrahman

Status

Unknown

Conditions

Xerostomia

Treatments

Drug: malic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT04756986
Malic acid in xerostomia

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

35 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

malic acid group
Experimental group
Description:
patients will receive a topical spray containing 1% malic acid
Treatment:
Drug: malic acid
placebo group
No Intervention group
Description:
patients will receive a topical placebo spray

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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