Skip to main content
OpenTrials
Completed

NCT Number: NCT05309070

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burning Mouth Syndrome Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of burning mouth syndrome

Exclusion criteria

  • pregnancy, breastfeeding or pregnancy planning
  • anamnestic data about active gastric or duodenal ulcer
  • decreased levels of serum iron or B vitamins

Treatment and study plan

N-acetyl cysteine

Dietary Supplement

Study group will receive N-acetyl cysteine in unmarked boxes, in a daily dose of 1200 mg during two months

Placebo

Other

Control group will receive a placebo, in unmarked boxes, during two months

Primary outcomes

  1. Change in quality of life

    Time frame: up to 8 weeks

    measured with OHIP-14 (Oral Health-Related Quality of Life questionnaire); the answer options with their respective values were as follows: 0 = never, 1 = rarely, 2 = sometimes, 3 = repeatedly, 4 = always, with a maximum score of 56. The higher the score, the worse quality of life.

Secondary outcomes

  1. Change in subjective symptoms of burning mouth

    Time frame: up to 8 weeks

    measured with VAS scale (visual analogue scale) grading from 0 to 10 (0 = without symptoms, 10 = worst possible symptoms)

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2022
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.