Malic Acid in Treatment of Xerostomia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Xerostomia
• Intervention / Treatment: Drug: malic acid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Faculty of Dentistry, Alexandria University
    • Contact: Shaimaa A Muhamed, BDS; Phone Number: 00201023314177; Email: shaymaa.abdelnabi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: malic acid group; patients will receive a topical spray containing 1% malic acid	Drug: malic acid; 1% malic acid spray; Other Names: hydroxybutanoic
No Intervention: placebo group; patients will receive a topical placebo spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman
• Investigators: Study Director: Eglal M Mousa, PHD, Alexandria University; Principal Investigator: Yasmin Y Gaweesh., PHD, Alexandria University; Principal Investigator: Noha K. Abo Aasy, PHD, Alexandria University; Principal Investigator: Shaimaa A. Muhamed, BDS, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: Malic acid in xerostomia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The investigators are planning to share the methods and the results of this study with all the investigators
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: he sharing access can be through PubMed when the study is published or through direct contact through this email
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes