Malic Acid in Treatment of Xerostomia

NCT04756986 | Unknown

• 1 other identifier: Malic acid in xerostomia
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• scoring of severity of xerostomia

  4 weeks

Study Arms (2)

malic acid group

EXPERIMENTAL

patients will receive a topical spray containing 1% malic acid

Drug: malic acid

placebo group

NO INTERVENTION

patients will receive a topical placebo spray

Interventions

malic acid DRUG

1% malic acid spray

Also known as: hydroxybutanoic

malic acid group

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Xerostomia

Interventions

malic acid

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Eglal M Mousa, PHD

  Alexandria University

  STUDY DIRECTOR

• Yasmin Y Gaweesh., PHD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Noha K. Abo Aasy, PHD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Shaimaa A. Muhamed, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication
• Access Criteria: he sharing access can be through PubMed when the study is published or through direct contact through this email

Locations

EG (1)