The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome

Last updated: May 9, 2025
Sponsor: University of Zagreb
Overall Status: Completed

Phase

N/A

Condition

Oral Facial Pain

Skin Wounds

Hyponatremia

Treatment

N-acetyl cysteine

placebo

Clinical Study ID

NCT05309070
05-PA-30-III-12/2021.
  • Ages 18-70
  • Female

Study Summary

The purpose of this study was to examine the efficacy of N-acetyl cysteine in the treatment of burning mouth syndrome. A control group of patients with burning mouth syndrome will receive a placebo. The effect of the therapy will be monitored with the help of the visual-analogue scale (VAS) and the oral health-related quality of life questionnaire (OHIP-14).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • clinical diagnosis of burning mouth syndrome

Exclusion

Exclusion Criteria:

  • pregnancy, breastfeeding or pregnancy planning

  • anamnestic data about active gastric or duodenal ulcer

  • decreased levels of serum iron or B vitamins

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: N-acetyl cysteine
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
February 28, 2025

Study Description

The research will include patients who come to the Department of Oral Medicine at the Faculty of Dentistry in Zagreb, and who have been diagnosed with burning mouth syndrome. It is planned to gather a total of 60 patients, 30 patients in the treatment group and 30 in the placebo group.

The purpose and protocol of the research will be explained to the patients. If they are willing to participate, they will sign an informed consent previously approved by the Ethics Committee of the Faculty of Dentistry. They will fill in the OHIP-14 questionnaire and the VAS scale, grading from 0-10, where 0 indicates a condition without symptoms, and 10 the strongest possible intensity of symptoms. They will be randomly assigned to a therapeutic or placebo group and will receive the medicine in an unmarked box. The drug will be taken for two months at a dose of 1200 mg per day. After that, they will come for a check-up and re-complete OHIP-14 and record the intensity of symptoms according to the VAS scale.

Connect with a study center

  • School of Dental Medicine, University of Zagreb

    Zagreb, 10000
    Croatia

    Site Not Available

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